[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bacterial-infections\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bacterial-infections":25},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,26,0,25,[9,38,67,92,124,159,191,220,255,285,314,342,362,387,413,439,465,487,511,540,566,612,634,664,683],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":4},"100644234","personalized-antibiotic-therapy---point-of-care-determination-of-blood-levels-of-beta-lactam-antibiotics-using-coated-blade-spray-ion-mobility-spectrometry-100644234",false,"NCT07666230","Personalized Antibiotic Therapy - Point-of-Care Determination of Blood Levels of Beta-Lactam Antibiotics Using Coated-Blade-Spray Ion Mobility Spectrometry","CBS-IMS","Inclusion Criteria:\n\n* Valid informed consent form (prospective, retrospective, or provided by a legal representative)\n* Antibiotic therapy with a beta-lactam antibiotic in the intensive care unit or intermediate care unit of the Department of General Surgery at UMG\n\nExclusion Criteria:\n\n* Patients without a valid informed consent form","ALL","18 Years",{"count":20,"type":21},200,"ESTIMATED","OBSERVATIONAL","A new analytical method for determining beta-lactam antibiotic concentrations in the blood of intensive care patients is to be evaluated. Patients receive antibiotic therapy with beta-lactam antibiotics in the general surgery intensive care unit. Blood samples are collected daily for routine clinical testing; a portion of these samples is used for the new method. The antibiotic levels, routinely measured using the gold standard, are documented and used as a reference point. The goal of the study is to establish a rapid and cost-effective method for determining beta-lactam antibiotic levels, which will subsequently enable rapid dose adjustment.",[25],"Bacterial Infections","NOT_YET_RECRUITING","2026-06-18",{"date":29,"type":30},"2026-06-24","ACTUAL",{"date":32,"type":21},"2026-09",{"date":34,"type":21},"2029-05",{"name":36,"class":37},"Dr. T. Perl","OTHER",{"id":39,"slug":40,"hasResults":12,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":4,"eligibilityCriteria":44,"healthyVolunteers":45,"sex":17,"minAge":46,"maxAge":46,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":49,"conditions":50,"keywords":53,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":4},"100642701","a-clinical-trial-of-the-13-valent-pneumococcal-polysaccharide-conjugate-vaccine-crm197tetanus-toxoid-100642701","NCT07648641","A Clinical Trial of the 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197\u002FTetanus Toxoid)","Phase IV Clinical Trial of the 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197\u002FTetanus Toxoid)","Inclusion Criteria:\n\n* Participants in the 2-month-old (minimum 6 weeks) group from the previous Phase III clinical trial of the 13-valent pneumococcal polysaccharide conjugate vaccine (CRM197, TT vector) (Protocol No.: CS-CTP-PCV)\n* The legal guardian or authorized representative is willing to provide identification documents\n* The legal guardian or authorized representative has provided informed consent, voluntarily signed the informed consent form, and is able to comply with the requirements of the clinical study protocol\n* The interval since the last dose of the primary vaccination series is ≥4 years\n\nExclusion Criteria:\n\n* Failure to complete blood draws at 1 and 2 years post-vaccination\n* Administration of any pneumonia vaccine after completion of the full vaccination series\n* Body temperature ≥37.3°C\n* Any other factors deemed by the investigator to render the participant unsuitable for participation in the clinical trial",true,"5 Years",{"count":48,"type":21},100,"This clinical study will enroll 100 participants from the 2-month-old (minimum 6 weeks) group who previously participated in the Phase III clinical trial of the 13-valent pneumococcal polysaccharide conjugate vaccine (CRM197, TT vector) (Protocol No.: CS-CTP-PCV), with 50 participants in each of the treatment and control groups, and who have completed blood sample collection for the 1-year and 2-year immunogenicity studies. All participants will have 3.0-3.5 mL of venous blood collected for the immunogenicity study.",[51,52,25],"Pneumococcal Infections","Streptococcal Infections",[54,55,51,56],"PCV13","13 valent Pneumococcal conjugate vaccine","Immune persistence","2026-06-10",{"date":59,"type":30},"2026-06-15",{"date":61,"type":21},"2026-07-01",{"date":63,"type":21},"2027-12-01",{"name":65,"class":66},"CanSino Biologics Inc.","INDUSTRY",{"id":68,"slug":69,"hasResults":12,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":76,"conditions":77,"keywords":78,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"100639557","clinical-efficacy-and-population-pharmacokinetics-of--lactams-in-cirrhotic-patients-100639557","NCT07612163","Clinical Efficacy and Population Pharmacokinetics of β-lactams in Cirrhotic Patients","Clinical Efficacy and Population Pharmacokinetics of β-lactams in Patients With Liver Cirrhosis: A Retro-prospective Observational Study","Inclusion Criteria:\n\nAge over 18 years Chinese patient: male or female Liver cirrhosis Diagnosed as bacterial infection Treated by β-lactams Serum concentration determined during therapy\n\nExclusion Criteria:\n\nDuration of β-lactams treatment less than 48 hours Patients renal or liver function not tested before treatment started Using more than two kinds of β-lactams",{"count":75,"type":21},1000,"Patients may benefit from the personalized β-lactams dosing strategy based on pharmacokinetics. The objective of this study is to retrospectively review, prospective observe and analyze the clinical outcomes of patients with liver cirrhosis, and to build a population pharmacokinetics model in the population mentioned above.",[25],[79,25,80],"β-lactam","Liver cirrhosis","RECRUITING","2026-05-21",{"date":84,"type":30},"2026-05-28",{"date":86,"type":30},"2023-12-31",{"date":88,"type":21},"2027-12-31",{"name":90,"class":37},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School",1,{"id":93,"slug":94,"hasResults":12,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":12,"sex":100,"minAge":18,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":120,"leadSponsor":122,"locationsCount":91},"100639817","large-algorithm-setting-and-validation-study-100639817","NCT07607470","Large Algorithm Setting and Validation Study","A Non-Significant Risk Specimen Collection Study to Obtain Vaginal Swab Samples for Algorithm Development and Testing","LAVA","Inclusion Criteria:\n\nBiologically female participants, ≥ 18 years of age, with at least one of the following symptoms of vaginitis:\n\n* Abnormal vaginal discharge\n* Vaginal or vulvar itching, burning, or irritation\n* Painful or uncomfortable intercourse\n* Vaginal odor\n* Painful or frequent urination\n\nExclusion Criteria:\n\n* Participants who do not meet the above-described inclusion criteria will be excluded from the study.\n* Previously enrolled in this study\n* Contraindication to vaginal swab sampling","FEMALE",{"count":75,"type":21},"In this pilot study, prospectively acquired clinician-collected and participant-collected vaginal swab specimens will be obtained from up to 1000 individuals with signs and symptoms of vaginitis to develop and validate a bacterial vaginosis diagnostic algorithm and evaluate the performance of the Nanopath assay.\n\nThe Nanopath assay is an amplification-free molecular test that detects pathogens associated with vaginitis. The performance of the Nanopath assay will be assessed by comparing Nanopath assay results to previously FDA-cleared commercial tests and yeast culture.",[25,104,105,106,107,108,109,110,111,112,113,114,115],"Bacterial Infections and Mycoses","Infections","Vaginitis","Vaginal Diseases","Genital Diseases, Female","Female Urogenital Diseases","Urogenital Disease","Candidiasis","Mycoses","Vulvovaginitis","Vulvar Diseases","Vaginosis, Bacterial","2026-05-20",{"date":118,"type":30},"2026-05-26",{"date":116,"type":21},{"date":121,"type":21},"2027-01",{"name":123,"class":66},"Nanopath, Inc",{"id":125,"slug":126,"hasResults":12,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":45,"sex":17,"minAge":18,"maxAge":131,"enrollmentInfo":132,"targetDuration":134,"studyType":22,"phases":4,"briefSummary":135,"conditions":136,"keywords":144,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":91},"100465142","emergency-pwas-in-respiratory-infectious-disease-100465142","NCT05336851","Emergency PWAS in Respiratory Infectious Disease","Emergency PanorOmic Wide Association Study in Respiratory Infectious Disease (ePWAS-RID)","Inclusion Criteria:\n\nPatients eligible for enrolment include:\n\nWith reference to previous inclusion criteria are:\n\n* Adults ≥18 years of age; AND\n* Suspected, acute, community-acquired, respiratory, infectious disease (scaRID)\\*; AND\n* Informed consent.\n\nNote: scaRID is defined according to ALL three criteria:\n\n1. Community acquired (not hospitalised for \\\u003C28 days); AND\n2. Acute infection (defined as symptom onset \\\u003C8 days and any ONE of reported fever or chills or aural temperature \\>37.5°C or hypothermia or leucocytosis or leucopaenia or new altered mental status); AND\n3. Probable respiratory infection - According to any ONE of:\n\n   1. new cough or new sputum production or\n   2. chest pain or\n   3. dyspnoea or\n   4. tachypnoea or\n   5. abnormal lung examination or\n   6. respiratory failure; or\n   7. physician's judgment (presenting with systemic or gastrointestinal symptoms).\n\nControl subjects will be drawn from two groups:\n\n* The worried well - adult patients with a National Early Warning Score (NEWS) \\\u003C3 and a temperature \\\u003C37.5°C.\n* Relatives or accompanying friends with no acute illness.\n\nExclusion Criteria:\n\n* Refusal of consent;\n* Recent hospitalisation (\\\u003C28 days);\n* Enrolled in another clinical trial\n* Cellulitis;\n* Skin or orthopaedic infections;\n* Urinary tract infection;\n* Acute abdominal sepsis;\n* Sexual transmitted disease;\n* Human immunodeficiency virus (HIV) infection;\n* Immunocompromised\u002Fpotential neutropenic fever;\n* Solid organ or haematopoietic stem-cell transplant within the previous 90 days;\n* Active graft-versus-host disease or bronchiolitis obliterans;\n* Severe traveller's disease requiring urgent hospitalisation and management including malaria, dengue, typhoid and other rickettsial diseases;\n* Stroke;\n* Toxidrome;\n* Non-organic acute psychosis.","100 Years",{"count":133,"type":21},2000,"1 Year","Develop an emergency PanorOmics Wide Association Study (ePWAS) for the early, rapid biological and pathophysiological characterisation of known and novel Infectious Diseases in adult patients presenting to emergency departments with suspected, acute, community-acquired respiratory infectious disease (scaRID).\n\nPhase 1\n\n1. Develop an ED-ID biobank (named ePWAS-RID). Phase 2\n2. Targeted research for the discovery of novel diagnostics, prognostics and therapeutics",[137,25,138,139,140,141,142,143],"Viral Infections","Fungal Infections","Mixed Infection","Mycobacterium Infection","Infection of Uncertain Aetiology","Pneumonia","Sepsis",[145,146,147,148,149],"Biobank","Diagnostics and Prognostics","Emergency Medicine","Multiomics and Panoromics","Respiratory Infectious Disease","2026-05-07",{"date":152,"type":30},"2026-05-12",{"date":154,"type":30},"2023-04-11",{"date":156,"type":21},"2028-05-01",{"name":158,"class":37},"The University of Hong Kong",{"id":160,"slug":161,"hasResults":12,"nctId":162,"briefTitle":163,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":166,"enrollmentInfo":167,"targetDuration":169,"studyType":22,"phases":4,"briefSummary":170,"conditions":171,"keywords":175,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":91},"100597742","prospective-clinical-registry-of-acute-treatment-and-long-term-assessment-of-children-meningitis-100597742","NCT07062445","Prospective Clinical Registry of Acute Treatment and Long-term Assessment of Children Meningitis","ATLAS-II","Inclusion Criteria:\n\n* Fever (axillary temperature ≥37.8°C) followed by two or more of the following symptoms\\*: severe headache, vomiting, altered consciousness (confusion, drowsiness, or irritability), photophobia (increased sensitivity to light), presence of seizures OR\n* Fever accompanied by at least one meningeal irritation sign, such as neck stiffness, Kernig's sign, or Brudzinski's sign OR\n* Sudden onset of fever and appearance of petechial skin rash or hemorrhagic suffusions\n\n  * In children younger than two years, in addition to the presentations listed above, consider fever with any of the following: irritability, persistent crying, somnolence, or bulging fontanelle.\n\nExclusion Criteria:\n\n* Refusal to provide consent for study participation","17 Years",{"count":168,"type":21},600,"180 Days","Prospective, multicenter, observational clinical registry of pediatric patients with acute infectious meningitis across approximately 20 public and private hospitals in Brazil. The study will include children under 18 years of age with suspected acute infectious meningitis. Data will be collected during hospitalization and post-discharge to evaluate clinical management, treatment and short and long-term outcomes. The study aims to generate real-world evidence on current practices and outcomes to support improvements in national care protocols.",[172,25,173,174],"Meningitis","Viral Meningitis","Fungal Meningitis",[176,177,178,179,180,181],"meningitis","bacterial","virus","corticosteroids","antibiotics","fungal","2026-04-29",{"date":184,"type":30},"2026-05-05",{"date":186,"type":30},"2026-03-29",{"date":188,"type":21},"2027-02",{"name":190,"class":37},"Hospital Israelita Albert Einstein",{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":12,"sex":100,"minAge":18,"maxAge":198,"enrollmentInfo":199,"targetDuration":201,"studyType":22,"phases":4,"briefSummary":202,"conditions":203,"keywords":205,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":91},"100621182","prospective-clinical-study-using-a-medical-device-rephegyn-as-an-adjuvant-in-the-treatment-of-fungal-candidiasis-and-bacterial-infections-100621182","NCT07367295","Prospective Clinical Study, Using a Medical Device (RepHegyn) as an Adjuvant in the Treatment of Fungal (Candidiasis) and Bacterial Infections","Prospective Clinical Study, Using a Medical Device as an Adjuvant in the Treatment of Fungal (Candidiasis) and Bacterial Infections: Evaluation of the Safety and Efficacy of Rephegyn Vaginal Ovules","Inclusion Criteria:\n\n* Age between 18 and 75 years\n* Signed written informed consent.\n* At least two subjective symptoms and two objective signs (at least moderate) of vaginal inflammation due to infection. Vaginal inflammation will be assessed based on six subjective symptoms (burning, pain, itching, irritation, dyspareunia, and dysuria) and four objective signs (swelling, vaginal discharge typical of the infection, pH, and presence of abrasion\u002Ferosion).\n* Confirmed recurrent bacterial vaginosis and candidiasis.\n* Patient able to maintain a patient diary during the study.\n* Patient is able to read and understand the language and content of the study materials, understands the requirements for follow-up visits, is willing to provide information at scheduled assessments, and is willing and able to comply with study requirements.\n\nExclusion Criteria:\n\n* Patients who do not sign the informed consent form\n* Other gynecological diseases, immunosuppressive diseases (e.g., HIV infection), or who are immunocompromised for reasons such as corticosteroid therapy, chemotherapy, anti-angiogenic agents, or immunosuppressants, patients with diabetes\n* Patients receiving antibiotics, anti-inflammatory agents, analgesics, antineoplastic drugs, or immunosuppressants within 4 weeks prior to study inclusion\n* History of connective tissue diseases, e.g., systemic lupus erythematosus, systemic sclerosis, Sjogren's syndrome, or mixed connective tissue disease\n* Known allergy to any component of the device\n* Subjects unable to understand the informed consent form or who have a high likelihood of non-compliance with study procedures and\u002For non-completion of the study according to the investigator's judgment\n* Pregnancy and breastfeeding\n* Time between the last day of the last menstrual period and the baseline visit \\>16 days or ≤5 days (for non-menopausal subjects).\n* Participation in other clinical studies","75 Years",{"count":200,"type":21},34,"12 Days","The medical device It is indicated to promote the re-epithelialization processes of the vaginal mucosa, in the prevention of vaginal conditions of bacterial and fungal origin, and as an adjuvant in their treatment.\n\nThe primary efficacy endpoint is based on the VAS symptom score (abnormal vaginal discharge, lower abdominal pain, dysuria, burning micturition, dyspareunia, vulvar irritation, and itching on a 10-point scale), specifically the percentage of patients with therapeutic success, defined as resolution of signs and symptoms of recurrent bacterial and fungal infections (total symptom score \\\u003C2) at the end of treatment.",[25,204],"Treatment of Fungal Infections, Candidiasis",[206,207,208,209,210],"candidiasis","bacterial infection","RepHegyn","pH restoring","barrier action","2026-04-13",{"date":213,"type":30},"2026-04-14",{"date":215,"type":21},"2026-05",{"date":217,"type":21},"2026-08",{"name":219,"class":66},"Innate srl",{"id":221,"slug":222,"hasResults":12,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":226,"eligibilityCriteria":227,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":230,"phases":231,"briefSummary":233,"conditions":234,"keywords":239,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":254},"100488822","phase-3-a-study-to-evaluate-efficacy-safety-and-pk-of-xembifystandard-medical-treatment-smt-compared-to-placebosmt-to-prevent-infections-in-participants-with-hgg-and-recurrent-or-severe-infections-associated-with-b-cell-chronic-lymphocytic-leukemia-multiple-myeloma-and-non-hodgkin-lymphoma-100488822","NCT05645107","A Study to Evaluate Efficacy, Safety, and PK of XEMBIFY®+Standard Medical Treatment (SMT) Compared to Placebo+SMT to Prevent Infections in Participants With HGG and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma","A Randomized, Multi-Center, Parallel, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of XEMBIFY® Plus Standard Medical Treatment Compared to Placebo Plus Standard Medical Treatment to Prevent Infections in Patients With Hypogammaglobulinemia and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma","EXCELL","Inclusion Criteria:\n\n* Participants ≥18 years of age at screening visit\n* Participants with documented and confirmed diagnosis of any of the below diseases:\n\n  * B-cell CLL according to International Workshop on CLL (iwCLL) criteria and RAI staging of intermediate (1 and 2) or high (3 and 4)\n  * MM according to the International Myeloma Working Group criteria (IMWG), R-ISS stage II or, III; or\n  * Histologically confirmed diagnosis of B-Cell NHL, Stage III or above (IV, Progressive\u002Frefractory, or recurrent\u002Frelapsed stage) according to the Lugano Classification.\n* Participants with HGG with IgG levels less than 5 g\u002FL. (Note: For MM subjects, the IgG level is adjusted by subtracting the M-protein \\[Mspike\\] to reflect the true polyclonal IgG concentration.)\n* Participants with documented history of at least one severe bacterial infection (bacterial or viral) or recurrent bacterial\u002Fviral infections (that is., ≥ 3 infections) within 12 months before the screening visit. Severe bacterial\u002Fviral infections ≥ Grade 3 (as defined by Common Terminology Criteria for Adverse Events \\[CTCAE\\] Grades).\n\nExclusion Criteria:\n\n* Participants with documented history of hematopoietic stem cell transplant (allogenic transplant in the previous 24 months, and autologous transplant in the previous 3 months) before Screening visit.\n* Participants currently receiving immunoglobulin replacement therapy (IgRT) or have received IgG replacement treatment (i.e., prior immune globulin replacement therapy) within 6 months before the screening visit.\n* Participants with active infections at time of screening visit. Specific supportive anti-infective prophylactic defined in the CLL National Comprehensive Cancer Network (NCCN) or iwCLL guidelines and\u002For local\u002Finternational guidelines for the CLL, and defined in local\u002Finternational guidelines for MM and NHL are allowed, or recommended in the updated labelling of specific active target disease medicines used during the participation in the trial is also allowed.\n* Participants with active second malignancies.\n* Participants with known primary immunodeficiency (PI).\n* Participants with a life expectancy less than 1.5 years.\n* Participants with clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with successful completion of the trial or place the subject at undue medical risk.\n* Participants have had a known serious adverse reaction (AR) to immunoglobulin or any anaphylactic reaction to blood or any blood-derived product.\n* Participants have a history of blistering skin disease, bleeding disorder, diffuse rash, recurrent skin infections, or other disorders where SC therapy would be contraindicated during the study based upon the Investigator's discretion.\n* Participants have known Selective Immunoglobulin A (IgA) Deficiency (with or without antibodies to IgA) (Note: exclusion is for the specific diagnostic entity. It does not exclude other forms of humoral primary immunodeficiency which have decreased IgA in addition to decreased IgG requiring IgG replacement).\n* Participants with severe known kidney disease \\[as defined by estimated glomerular filtration rate \\[eGFR\\] less than (\\<) 30 milliliter (mL)\u002Fmin\u002F1.73 square meter (m2)\\] as determined by the Principal Investigator.\n* Participants that have liver enzyme levels (alanine aminotransferase \\[ALT\\], aspartate aminotransferase \\[AST\\], gammaglutamyl transferase \\[GGT\\], or lactate dehydrogenase \\[LDH\\]) greater than 3 times the upper limit of normal (ULN) at the Screening Visit as defined by the testing laboratory.\n* Participants have a history (either 1 episode within the year prior to the Screening Visit or 2 previous episodes over a lifetime) of or current diagnosis of thromboembolism (example, myocardial infarction, cerebrovascular accident, or transient ischemic attack) or deep venous thrombosis.\n* Participants currently have a known hyperviscosity syndrome or hypercoagulable states.\n* Participants have a known previous infection or clinical signs and symptoms consistent with current hepatitis B virus or hepatitis C virus infection.\n* Participants with non-controlled arterial hypertension (systolic blood pressure \\[SBP\\] greater than 140 millimeters of mercury (mmHg) and\u002For diastolic blood pressure \\[DBP\\] greater than 90 mmHg), and\u002For a heart rate (HR) greater than100 bpm.\n* Participants with known substance or prescription drug abuse within 12 months before the Screening Visit.\n* Participants have participated in another clinical trial within 30 days prior to screening (observational studies without investigative treatments \\[non-interventional\\] are permitted).",{"count":229,"type":21},386,"INTERVENTIONAL",[232],"PHASE3","The primary purpose of the study is to evaluate whether biweekly administered XEMBIFY® plus Standard Medical Treatment (SMT) over a one-year period will reduce the rate of major bacterial infections per participant per year in B-cell CLL, MM, and NHL participants with hypogammaglobulinemia (HGG) in comparison to the Placebo plus SMT group.",[235,25,236,237,238],"Hypogammaglobulinemia","B-cell Chronic Lymphocytic Leukemia","Multiple Myleoma","Non-Hodgkin Lymphoma",[240,241,242,243,244,245],"XEMBIFY","CLL","SMT","Hypogammaglobulinemia (HGG)","MM","NHL","2026-04-08",{"date":211,"type":30},{"date":249,"type":30},"2022-12-26",{"date":251,"type":21},"2026-06",{"name":253,"class":66},"Grifols Therapeutics LLC",62,{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":262,"enrollmentInfo":263,"targetDuration":4,"studyType":230,"phases":265,"briefSummary":267,"conditions":268,"keywords":272,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":91},"100570192","healthrelated-quality-of-life-and-experiences-of-a-heart-rehabilitation-programme-after-care-for-infective-endocarditis-100570192","NCT06704048","Healthrelated Quality of Life and Experiences of a Heart Rehabilitation Programme After Care for Infective Endocarditis.","Healthrelated Quality of Life and Experiences of a Heart Rehabilitation Programme After Care for Infective Endocarditis. A Quantitave and Qualitative Study With Mixed Methods.","Inclusion Criteria:\n\n* Diagnosis of infective endocarditis (IE) based on Dukes ISCVID criteria and discharged after treatment for IE from the Department of Infectious Diseases, Hospital of Halmstad, Region Halland, Sweden.\n\nExclusion Criteria:\n\n* Not able to do a bicycle ergometer test or training.","90 Years",{"count":264,"type":21},50,[266],"NA","How does health develop after Infective endocarditis (IE)? Can the health of patients with IE be improved by participation in the physical exercise training within cardiac rehabilitation program?\n\nParticipants will:\n\n* Answer digitally surveys on the perceived health for 4 times during 1 year\n* Participate in interviews on patient's experiences of health and rehabilitation 1 time before and 2 times after the training program during I year.\n* Be physically evaluated by a physiotherapist before and after the progam of physical exercise training within cardiac rehabilitation.\n* Do individual exercises in a group led by a physiotherapist 2 times weekly during 12 weeks.",[269,25,270,271],"Infective Endocarditis","Cardiac Rehabilitation","Patient Participation",[269,25,271,273,274,275],"Interview","Qualitative Research","Cardiac rehabilitation","2026-04-01",{"date":278,"type":30},"2026-04-07",{"date":280,"type":30},"2024-08-22",{"date":282,"type":21},"2035-08",{"name":284,"class":37},"Region Halland",{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":289,"acronym":290,"eligibilityCriteria":291,"healthyVolunteers":45,"sex":17,"minAge":292,"maxAge":293,"enrollmentInfo":294,"targetDuration":4,"studyType":230,"phases":296,"briefSummary":297,"conditions":298,"keywords":301,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":310,"leadSponsor":312,"locationsCount":91},"100629122","viromes-in-infants-presenting-with-a-septic-syndrome-100629122","NCT07470541","Viromes in Infants Presenting With a Septic Syndrome","V-NOURSSE","Inclusion criteria :\n\nFor participants :\n\n* Age \\\u003C 3 months\n* Fever ≥38°C confirmed in pediatric emergency department\n\nFor control group :\n\n* Age \\\u003C 3 months\n* Children requiring general anesthesia or managed in the pediatric emergency department, or during hospitalization or consultation, for a non-infectious condition requiring venipuncture\n\nExclusion criteria :\n\nFor participants :\n\n* Lack of parental\u002Flegal guardian consent\n* Lack of affiliation with a social security scheme\n* Antibiotic treatment within 8 days prior to inclusion\n\nFor control group :\n\n* Lack of parental\u002Flegal guardian consent\n* Lack of affiliation with a social security scheme\n* Antibiotic treatment within 8 days prior to inclusion\n* Infectious episode within 8 days prior to inclusion","0 Months","3 Months",{"count":295,"type":21},130,[266],"Fever in infants younger than 3 months is a common reason for emergency department visits and is associated with a significant risk of serious bacterial infections. Because it is difficult to distinguish bacterial from viral infections at presentation, management is often aggressive and includes invasive procedures, hospitalization, and empiric antibiotic therapy.\n\nDespite advances in molecular diagnostics, the etiology of fever remains unidentified in a substantial proportion of cases. This study aims to assess the presence of pathogenic viruses in respiratory and intestinal samples from febrile infants younger than 3 months compared with afebrile controls, and to explore associations with clinical, biological, environmental, and socio-economic factors",[299,300,25],"Fever","Viral Infection",[302,303,304,305],"fever in infants under 3 months","Viruses","Respiratory infection multiplex PCR","Virome","2026-03-16",{"date":308,"type":30},"2026-03-17",{"date":276,"type":21},{"date":311,"type":21},"2028-03-31",{"name":313,"class":37},"University Hospital, Montpellier",{"id":315,"slug":316,"hasResults":12,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":4,"eligibilityCriteria":320,"healthyVolunteers":45,"sex":17,"minAge":321,"maxAge":322,"enrollmentInfo":323,"targetDuration":4,"studyType":230,"phases":324,"briefSummary":325,"conditions":326,"keywords":327,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":341},"100594310","phase-3-a-study-to-evaluate-the-immunogenicity-and-safety-of-13-valent-pneumococcal-conjugate-vaccine-pcv13i-in-healthy-infants-aged-2-months-minimum-6-weeks-100594310","NCT07017777","A Study to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13i) in Healthy Infants Aged 2 Months (Minimum 6 Weeks)","A Phase III, Observer-blind, Randomized Controlled Trial to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13i) in Healthy Infants Aged 2 Months (Minimum 6 Weeks)","Inclusion Criteria:\n\n* Healthy infants with stable clinical conditions aged 2 months (42-90 days) at the time of screening, based on medical history and clinical assessment by the investigator. Infants will be eligible starting from the day they turn 6 weeks of age.\n* Infant's parent or legal guardian must be able and willing to provide informed consent for the infant's participation in the study.\n* Participants and their parent or legal guardian must demonstrate the ability to comply with all trial procedures and be available for the entire follow-up duration.\n* The infant's parent or legal guardian must have an easily identifiable and stable place of residence within the study area, be available for the duration of trial participation, and have access to a reliable means of telephone contact for communication with the study team.\n\nExclusion Criteria for the first dose:\n\n* Infants born at \\\u003C35 weeks of gestation.\n* Infants who have previously received any pneumococcal vaccine.\n* Infants currently participating in or who have recently participated in another interventional clinical trial.\n* Infants with an axillary temperature of ≥37.8°C at the time of enrollment (the participant must be deferred until recovery. The visit may be rescheduled when this criterion is met.)\n* Infants with any congenital abnormalities, chronic medical conditions, or genetic disorders, severe malnutrition, inherited disease and others, that in the investigator's judgment, may interfere with the study outcomes.\n* History of anaphylactic shock\n* History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the experimental and control vaccine\n* History of epilepsy and convulsions.\n* Have received immunosuppressive treatment, cytotoxic treatment, systemic steroid treatment for more than 2 weeks, etc. (excluding local treatment, surface treatment of acute non-concurrent dermatitis, or spray treatment of allergic rhinitis).\n* Received or planned to receive blood\u002Fplasma products or immunoglobulins throughout the study period or prior to study vaccination.\n* History of coagulation disorders or blood conditions that could cause anemia or excess bleeding as judged by the investigator.\n* Infants with known or suspected immunodeficiency, as determined by medical history and\u002For physical examination.\n* Administration of other vaccines within 7 days prior to enrollment.\n* Any history or current evidence of a condition or therapy that could confound study results, interfere with participation, or is not in the best interest of the participant, as judged by the investigator.\n* The participant is a direct descendant (child or grandchild) of any person employed by the Sponsor, the contract research organization (CRO), the investigator, or study site personnel.\n* Any other condition or situation that, in the investigator's judgment, might interfere with the study or pose additional risks to the participant.\n\nIndividual termination criteria for subsequent doses:\n\n* Severe allergic reaction after the previous vaccination.\n* Serious adverse events caused by the previous vaccination that is not suitable for subsequent vaccination(s) as judged by the investigator.\n* Newly identified symptoms or newly occurred cases after the first vaccination that do not meet the inclusion criteria for the first dose, or that meet the exclusion criteria for the first dose. The decision to discontinue participation is determined by the investigator.\n* Other reasons for exclusion considered by the investigator.","6 Weeks","2 Months",{"count":168,"type":21},[232],"This is a Phase 3 randomized, observation-blinded, active-controlled, parallel-group clinical trial designed to evaluate the immunogenicity, safety, and functional antibody response of the experimental vaccine versus the control vaccine in healthy Thailand infants vaccinated at a 2+1 schedule (2 months, 4 months and 12-15 months). The trial will enroll approximately 600 healthy infants aged 2 months (at least 6 weeks) who will be randomly assigned in a 1:1 ratio to receive either the experimental or control vaccine, with 100 in each group (200 in total) randomized to subgroups and subject to additional immunogenicity assessments. All participants will be evaluated for solicited adverse events for 7 days and unsolicited adverse events for 30 days post each vaccination. Immunogenicity evaluation will be performed in all participants at baseline and post the booster dose, while the sub-cohort participants will be evaluated for post primary series immunogenicity additionally.",[51,52,25],[328,55,329,330,331,332],"PCV13i","Pneumococcal infections","2 months of age","Safety","Immunogenicity","2026-02-25",{"date":335,"type":30},"2026-02-27",{"date":337,"type":30},"2025-11-14",{"date":339,"type":21},"2028-05-15",{"name":65,"class":66},3,{"id":343,"slug":344,"hasResults":12,"nctId":345,"briefTitle":346,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":230,"phases":350,"briefSummary":352,"conditions":353,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":360,"locationsCount":91},"100382758","phase-1-18ffluoropropyl-trimethoprim-18ff-tmp-petct-imaging-to-evaluate-biodistribution-and-kinetics-in-human-subjects-100382758","NCT04263792","[18F]Fluoropropyl-Trimethoprim ([18F]F-TMP) PET\u002FCT Imaging to Evaluate Biodistribution and Kinetics in Human Subjects","Inclusion Criteria:\n\n* At least 18 years of age\n* Known or suspected bacterial infection, per clinical documentation of suspected infection (e.g. lab results, pathology results, physician progress notes, clinical symptoms of infection)\n* Able to understand the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures\n\nExclusion Criteria:\n\n* Antibiotic therapy with trimethoprim within 48h of the baseline PET\u002FCT scan\n* Inability to tolerate imaging procedures, in the opinion of an investigator or treating physician\n* Unstable or other severe medical or psychological comorbidities that would compromise the subject's safety or successful participation in the study, in the opinion of an investigator or treating physician\n* Pregnant or breast feeding patients; a urine pregnancy test will be performed in women of child-bearing potential prior to \\[18F\\]F-TMP injection, to confirm non-pregnant status",{"count":349,"type":21},20,[351],"PHASE1","The purpose of this study is to study a radioactive tracer, a type of imaging drug that is injected into the body to see how it is taken up in sites of active infection using an imaging procedure called Positron Emission Tomography\u002FComputed Tomography (PET\u002FCT).",[25],"2026-02-02",{"date":356,"type":30},"2026-02-05",{"date":358,"type":30},"2020-02-07",{"date":121,"type":21},{"name":361,"class":37},"University of Pennsylvania",{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":4,"eligibilityCriteria":368,"healthyVolunteers":45,"sex":17,"minAge":18,"maxAge":369,"enrollmentInfo":370,"targetDuration":4,"studyType":230,"phases":372,"briefSummary":373,"conditions":374,"keywords":375,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":386},"100600951","phase-1-a-study-to-investigate-safety-and-pharmacokinetics-of-intravenous-cefiderocolxeruborbactam-in-participants-with-renal-impairment-100600951","NCT07104162","A Study to Investigate Safety and Pharmacokinetics of Intravenous Cefiderocol\u002FXeruborbactam in Participants With Renal Impairment","A Phase 1, Open-label, Single-dose Study to Determine the Safety and Pharmacokinetics of Intravenous Cefiderocol\u002FXeruborbactam (S-649228) in Participants With Renal Impairment","Inclusion Criteria:\n\nAn individual will be eligible to be included in the study only if all of the following criteria apply:\n\nAll participants\n\n* Able to understand the study conduct and tasks required of the participants, sign the informed consent form and willing to cooperate with all tests and examinations required by the protocol.\n* Aged 18 to 80 years, inclusive, at the time of consent.\n* If male, agrees to be sexually abstinent or agrees to use 2 approved methods of contraception (refer to Inclusion Criterion 4) when engaging in heterosexual activity from Day -1 through 90 days following the last administration of the study intervention, and to not donate sperm during this same period of time. If the sexual partner is surgically sterile, contraception is not necessary.\n* If female of childbearing potential, must either be sexually abstinent for 14 days prior to Day -1 and remain so through 30 days following dosing of the study intervention or have been using (or agree to use) 2 acceptable methods of birth control when engaging in heterosexual activity\n* If female of childbearing potential, must agree not to donate eggs (ova, oocytes) for the purpose of reproduction from Day -1 through 30 days following the last administration of the study intervention.\n* If female of non-childbearing potential, must either be postmenopausal (defined as 12 months spontaneous amenorrhea) with serum follicle stimulating hormone (FSH) level in the laboratory-defined postmenopausal range or have undergone sterilization procedures at least 6 months prior to Day -1; documentation of sterilization procedure must be obtained\n* Has a BMI ≥ 18.5 kg\u002Fm2 and ≤ 45 kg\u002Fm2, inclusive.\n* Has negative test results for hepatitis B surface antigen (HBsAg), anti-Hepatitis C virus (HCV) antibody, anti-human immunodeficiency virus (HIV) antibody, and SARS-CoV-2.\n\nParticipants with normal renal function:\n\n* Has an eGFR ≥ 90 mL\u002Fmin calculated using the 2021 CKD-EPI equation adjusted for the participant's BSA at screening\n* Meets matching criteria for age, BMI, and gender of pooled renally impaired participants as defined in the protocol.\n\nParticipants with renal impairment\n\n* Stable mild to severe renal impairment, as assessed by eGFR calculated using the 2021 CKD-EPI equation adjusted for the participant's BSA at screening\n* Is on a stable medication regimen\n\nParticipants with ESRD on hemodialysis\n\n* Receiving stable IHD at least 3 times a week for at least 3 months, using an arteriovenous fistula, graft, or catheter\n* Is on a stable medication regimen\n\nExclusion Criteria:\n\nAn individual must not meet any of the following exclusion criteria to be eligible to participate in the study:\n\n* Has unstable or new medical condition(s)\n* Has had surgery under general anesthesia within the past 3 months prior to Day -1, determined by the investigator to be clinically relevant.\n* Documented hypersensitivity reaction or anaphylaxis to any medication.\n* History of seizures, convulsions\n* Current evidence or history of malignancy\n* If female, is pregnant, lactating, or has a positive pregnancy test at screening or Day -1.\n* Received any investigational drug within 30 days or 5 half-lives, whichever is longer, of Day -1 for the current clinical study.\n* Blood donation or significant blood loss (ie, \\> 500 mL) within 56 days prior to Day -1.\n* Plasma or platelet donation within 14 days prior to Day -1.\n* Any acute illness requiring antibiotic drug therapy within 30 days prior to Day -1 or a febrile illness within 7 days prior to Day -1.\n* Vigorous exercise from 72 hours prior to Day -1 through the final FU\u002FEOS Visit.\n* Positive drug test at the Screening Visit or Day -1\n* Positive alcohol test at screening or Day -1 and\u002For recent history (ie, within 6 months prior to Day -1) of excessive alcohol intake.\n* Concurrent use of medications known to affect the elimination of serum creatinine and competitors of renal tubular secretion\n* Employees of the investigative site involved in this study.\n* Unable or unwilling to adhere to the study-specified procedures and restrictions.\n* QTcF interval \\> 500 msec, previous history or family history of prolonged QT syndrome at screening or Day -1.\n* Use of products containing alcohol, caffeine, xanthine, or ephedrine within 24 hours prior to Day -1; use of alcohol 48 hours prior to Day -1; use of proton pump inhibitors (eg, omeprazole and pantoprazole) 7 days prior to Day -1, including both over-the-counter (OTC) and prescription drugs in these categories; or consumption of grapefruit\u002Fgrapefruit juice, Seville oranges, pomelo, exotic citrus fruits or grapefruit hybrids or juices containing such products within 7 days prior to Day -1.\n* Has any clinically significant abnormalities in laboratory values at screening or Day -1, defined in the study protocol.\n\nParticipants with normal renal function:\n\n• Abnormal and clinically significant findings on physical examination, medical history, serum chemistry, hematology, or urinalysis per Investigator discretion.\n\nParticipants with renal impairment, including those on IHD:\n\n* Abnormal and clinically significant findings on physical examination, medical history, serum chemistry, hematology, or urinalysis per Investigator discretion. Participants in the renal impairment group will have consideration for the degree of renal impairment and presence of comorbidities.\n* Has renal disease secondary to hepatic disease (hepatorenal syndrome)","80 Years",{"count":371,"type":21},40,[351],"A Phase 1, Open-label, Single-dose Study to Determine the Safety and Pharmacokinetics of Intravenous Cefiderocol\u002FXeruborbactam (S-649228) in Participants with Renal Impairment",[25],[376],"beta-lactamase inhibitor","2025-11-20",{"date":379,"type":30},"2025-11-25",{"date":381,"type":30},"2025-09-16",{"date":383,"type":21},"2026-12-23",{"name":385,"class":66},"Qpex Biopharma, Inc.",2,{"id":388,"slug":389,"hasResults":12,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":4,"eligibilityCriteria":393,"healthyVolunteers":45,"sex":17,"minAge":18,"maxAge":394,"enrollmentInfo":395,"targetDuration":4,"studyType":230,"phases":397,"briefSummary":398,"conditions":399,"keywords":403,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":91},"100608879","phase-1-phase-i-study-of-singlemultiple-ascending-doses-of-jkn2501-for-injection-in-chinese-healthy-volunteers-100608879","NCT07207291","Phase I Study of Single\u002FMultiple Ascending Doses of JKN2501 for Injection in Chinese Healthy Volunteers","A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of JKN2501 for Injection in Chinese Healthy Volunteers","Inclusion Criteria:\n\n* Voluntary informed consent; able to comply with study requirements and communicate effectively.\n* Healthy subjects aged 18-45 years (inclusive) at screening.\n* BMI 19.0-26.0 kg\u002Fm² (inclusive); weight ≥50 kg (male) or ≥45 kg (female).\n* Vital signs, physical examination, ECG, laboratory tests, chest X-ray, and abdominal ultrasound results judged as normal or clinically insignificant by the investigator.\n* Agreement to use effective non-pharmaceutical contraception from signing ICF until 90 days after last dose; no sperm\u002Fegg donation plans during this period.\n\nExclusion Criteria:\n\n* Pregnant\u002Flactating women; positive pregnancy test; unprotected sex within 2 weeks prior to dosing.\n* Investigator-determined history or presence of clinically significant disorder that may affect safety or trial participation.\n* Use of drugs known to inhibit\u002Finduce hepatic metabolism within 4 weeks, or any medication (prescription, OTC, herbal, vitamins) within 2 weeks prior to dosing; planned use during the trial.\n* Major surgery within 3 months prior to screening or planned during trial; history of surgery potentially affecting results.\n* History of febrile illness or active infection within 2 weeks prior to screening.\n* Blood loss\u002Fdonation \\>400 mL within 3 months prior to screening, or received blood products; plans to donate blood during trial or within 30 days after last dose.\n* History of significant food\u002Fdrug allergy, or allergy to JKN2501\u002Fexcipients.\n* Excessive alcohol consumption; inability to abstain from alcohol from 48h pre-dose until end of study.\n* Smoking ≥5 cigarettes\u002Fday within 3 months prior to screening; inability to abstain from smoking from 48h pre-dose until end of study.\n* History of drug abuse; positive urine drug screen at baseline (Day -1).\n* Positive alcohol breath test at baseline (Day -1).\n* Participation in another interventional clinical trial within 3 months prior to screening or planned during this trial.\n* Estimated glomerular filtration rate (eGFR) \\\u003C90 mL\u002Fmin.\n* Serum total calcium below lower limit of normal at screening.\n* Investigator-determined unsuitable venous access for PK sampling\u002Finfusion, or history of adverse symptoms\u002Fphobias related to infusion\u002Fphlebotomy.\n* Excessive daily intake of tea, coffee, or caffeinated beverages within 3 months prior to screening.\n* Consumption of grapefruit, Seville oranges, caffeine, or xanthine-rich foods\u002Fbeverages within 48h prior to first dose; inability to abstain during the trial.\n* History of QTc prolongation; or investigator-determined clinically significant ECG abnormalities at screening\u002Fbaseline.\n* Any other condition deemed by the investigator to make the subject unsuitable for participation.","45 Years",{"count":396,"type":21},66,[351],"This Phase I study is a randomized, double-blind, placebo-controlled, dose-escalation trial conducted at a single center. It consists of two parts:\n\nPart 1 (SAD): Evaluates the safety, tolerability, and pharmacokinetics (PK) of single ascending intravenous doses of JKN2501 in healthy adults. Biological samples (blood, urine, feces) will be collected for PK analysis.\n\nPart 2 (MAD): Evaluates the safety, tolerability, and PK of multiple ascending intravenous doses of JKN2501 in healthy adults.\n\nDose levels may be adjusted based on emerging safety, tolerability, and PK data from preceding cohorts.",[25,400,401,402],"Urinary Tract Infections","Intra-Abdominal Infections","Respiratory Tract Infections",[25],"2025-09-28",{"date":406,"type":30},"2025-10-03",{"date":408,"type":30},"2025-08-22",{"date":410,"type":21},"2026-03-19",{"name":412,"class":66},"Joincare Pharmaceutical Group Industry Co., Ltd",{"id":414,"slug":415,"hasResults":12,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":4,"eligibilityCriteria":419,"healthyVolunteers":12,"sex":17,"minAge":420,"maxAge":421,"enrollmentInfo":422,"targetDuration":4,"studyType":230,"phases":424,"briefSummary":426,"conditions":427,"keywords":428,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":341},"100604184","phase-2-pharmacokinetic-and-safety-study-of-metronidazole-oral-suspension-in-pediatric-patients-with-anaerobic-bacterial-infection-100604184","NCT07146217","Pharmacokinetic and Safety Study of Metronidazole Oral Suspension in Pediatric Patients With Anaerobic Bacterial Infection","An Open-Label, Single-Arm, Pharmacokinetic and Safety Study of Likmez® (Metronidazole Oral Suspension) in Pediatric Patients Aged 12 Months to \u003C4 Years With Anaerobic Bacterial Infection","Inclusion Criteria:\n\n* Age between ≥ 12 months and \\\u003C 4 years till the time of dosing in the study\n* Sufficient venous access to permit cannulation for required blood sample collection.\n* Ability to swallow oral liquids.\n* Clinical diagnosis with suspected or culture-confirmed anaerobic bacterial infection with pathogens known to be sensitive to metronidazole and requiring treatment for any of the below mentioned infections:\n\n  1. Septicaemia and Bacteraemia\n  2. Intra-abdominal infections (including peritonitis, intra-abdominal abscess, and liver abscess)\n  3. Bone and joint infections (including osteomyelitis)\n  4. Lower respiratory tract infections (including pneumonia, empyema, and lung abscess)\n* Patients with clinical diagnosis of polymicrobial infection who can be administered Likmez® with other antibacterial agents without clinically significant drug-drug interactions. Note: These patients will be allowed concomitant administration with other antibacterial drugs, not having an interaction with metronidazole (Refer APPENDIX B: List of Antibiotic Drugs Having Interaction with Metronidazole, for the list of antibiotic drugs having interaction with metronidazole). If co-administration of such medications cannot be avoided, PI should consider taking steps to minimize the risk of QT\u002FQTc interval prolongation and torsade de pointes (TdP), such as electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP.\n* Any of the above mentioned clinical conditions, which would allow them to initiate the treatment with IV or oral anti-bacterial drugs with activity against anaerobic bacteria (e.g., IV treatment such as a betalactam\u002Fbeta-lactamase inhibitor or a cephalosporin plus metronidazole; or oral treatment such as amoxicillin, amoxicillin-clavulanate, or azithromycin) followed by treatment with i.e. Likmez® at 7.5 mg\u002Fkg, to complete the treatment course and are able to provide PK samples for the study.\n* Parents\u002Flegal guardians of the patient have provided Written Informed Consent prior to initiation of any protocol-specific procedures.\n\nExclusion Criteria:\n\n* History of anaphylactic reaction to metronidazole or other nitroimidazole derivatives (e.g., tinidazole).\n* Presence of clinically significant encephalopathy or peripheral neuropathy.\n* Presence or history of clinically significant convulsive seizure disorders.\n* Presence or history of any hematologic condition or blood dyscrasia which may result in leukopenia (even if leukocyte count is normal at screening).\n* Abnormal laboratory results for the following analyses showing any of the following abnormal results:\n\n  1. Aspartate aminotransferase (AST), alanine transaminase (ALT)\\>2 X the upper limit of the reference range\n  2. WBC count \\\u003C3.0 X 109 \u002FL\n  3. Total bilirubin ≥20 μmol\u002FL (1.17 mg\u002FdL); except in patients with isolated elevation of indirect bilirubin relating to Gilbert syndrome\n  4. Estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m2 using the Bedside Schwartz methods for estimation (eGFR = 41.3 x height\u002Fserum creatinine (Scr), where height is in meters and Scr in mg\u002FdL)\n  5. Hemoglobin \\\u003C8 g\u002FdL\n  6. Platelets \\\u003C100,000\u002FμL\n* History or presence of any clinically significant disease or disorder that, in the opinion of the investigator, would put the patient at risk or would potentially influence the results of the study (e.g. evidence of gastrointestinal, hepatic, or renal disease that could affect absorption, distribution, metabolism, or excretion of the orally administered study drug).\n* Patients with a history of hereditary fructose intolerance (HFI) or rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.\n* Patients with a known sensitivity to glucose (e.g. patients with a diagnosis of diabetes or patients taking a ketogenic diet).\n* Patients with a history of Severe cutaneous adverse reactions (SCARs), including Stevens Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP).\n* Patients who have used disulfiram within the last two weeks prior to enrollment in study.\n* Patients who have consumed products containing propylene glycol within a week prior to enrollment in study and who wish to continue products containing propylene glycol during the study and for at least three days after the end of treatment period.\n* Patients with known status of Cockayne syndrome.\n* Patients with treatment with any another drug that is known to have pharmacokinetic interaction \\[For example: barbiturates such as phenytoin or phenobarbital\\] with metronidazole, within 30 days prior to enrollment or within 5.5 half-lives of the drug, (whichever is longer), until the end of study.\n* Previous exposure to metronidazole within 30 days of enrollment.\n* Patients with a known history of Hepatitis B virus (HBV), Hepatitis C virus (HCV), Human immunodeficiency virus (HIV), and latent tuberculosis (TB) infections.\n* Previous participation in this study.","12 Months","4 Years",{"count":423,"type":21},30,[425],"PHASE2","This is an open-label, single-arm, pharmacokinetic and safety study of Likmez® in pediatric patients aged 12 months to \\\u003C4 years with anaerobic bacterial infection",[25],[429],"Anaerobic Bacterial Infection","2025-08-21",{"date":432,"type":30},"2025-08-28",{"date":434,"type":21},"2025-08",{"date":436,"type":21},"2026-10",{"name":438,"class":66},"Saptalis Pharmaceuticals LLC",{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":449,"conditions":450,"keywords":454,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":459,"completionDateStruct":460,"leadSponsor":462,"locationsCount":91},"100595224","the-accredit-2-study-100595224","NCT07029672","The AcCREDiT 2 Study","Acute Respiratory Infections and Chronic Respiratory Disease Exacerbation Characterisation and Personalised Treatment Platform Study 2","ACCREDIT2","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Clinically suspected acute respiratory infection or exacerbation of chronic respiratory disease\n* Availability of respiratory tract sample\n\n  1. Spontaneously breathing patients are able to produce a sputum sample\n  2. Mechanically ventilated patients in intensive care are due to have an Bronchoalveolar lavage or non-directed bronchial lavage for a clinical indication\n* Due to receive either:\n\n  1. an anti-infective agent (e.g. antibiotic, antiviral or antifungal) OR\n  2. a systemic anti-inflammatory agent (e.g. corticosteroid)\n* Valid informed consent, assent or enrolment through deferred consent\n* Re-enrolment will be allowed if presenting for a separate acute event\n\nExclusion Criteria:\n\n* Alternate respiratory cause of presentation in the opinion of the treating physician (e.g. pulmonary embolism, heart failure, etc.)\n* High clinical likelihood of infection with a Hazard Group 3 pathogen (e.g. tuberculosis, anthrax, plague)",{"count":448,"type":21},120,"The ACCREDIT study - Acute respiratory infections and chronic respiratory disease exacerbations characterisation and personalised treatment platform study 2 (AcCREDiT 2).\n\nPatients with respiratory infections (such as pneumonia) or exacerbations of chronic respiratory conditions (such as emphysema) often require hospital admission. Infections or exacerbation are commonly caused by bacteria, viruses or fungi. In at least a quarter of patients no infectious cause of the exacerbation is found. Depending on the cause of the respiratory infections or exacerbations of chronic respiratory condition patients require prompt treatment with anti-infective drugs (antibiotics, anti-fungal or antiviral drugs) or anti-inflammatory drugs such as corticosteroids.\n\nPatients with respiratory infection or exacerbations of chronic respiratory conditions develop symptoms such as cough, sometimes with sputum, fever or breathlessness. These symptoms can be similar across several conditions, many of which are not due to infection (for example heart failure or blood clots in the lungs). When assessing patients with respiratory symptoms, clinicians face the challenge of limited information in the early stages of care as it takes three days to identify infectious organisms in the laboratory. Even when an infection is strongly suspected, distinguishing bacterial from viral or fungal infections on clinical grounds alone is difficult. This uncertainty often leads clinicians to prescribe a number of treatments, including antibiotics, before a clear diagnosis is made. Timely treatment is crucial for success and improved patient outcomes, especially for critically ill patients admitted to the intensive care unit (ICU). However, antibiotics may cause side effects, such as sickness and diarrhoea, and overuse of antibiotics leads to antibiotic resistance, making antibiotics less effective when they are really needed. Giving antibiotics to patients with an infection or exacerbation and avoiding antibiotics in patients without an infection requires rapid diagnostic tests. Furthermore, giving antibiotics prior to taking samples to diagnose infection can affect the sample being tested making it more likely to not give a useful result. For a diagnostic test for infection to be most useful it needs to be collected before an antibiotic is given - this is true for both clinical tests and those research tests which are clinical tests in development.\n\nModern technologies allow testing for an infection in hours rather than days. In order to understand how effective these technologies are, samples need to be taken from patients before they start treatment. In routine NHS care samples to test for infection should be taken before treatment has been started. However, in research studies samples are often taken up to a day after treatment has started which affects how effective the test is at finding infection. The forerunner to this study, called AcCREDiT, proposed investigating very rapid ways of identifying individuals with respiratory infection and exacerbation. However, the study team encountered challenges during the informed consent process, particularly with acutely unwell patients. Therefore, the AcCREDiT-2 was designed in collaboration with patients and public contributors to look at the feasibility of a modified informed consent process: verbal consent, assent for individuals with capacity to consent for themselves, and deferred consent.\n\nAcCREDiT-2 will be an observational study, meaning that no treatment will be changed, and no experimental drugs or tests used to influence the clinical care of participants. AcCREDiT-2 will also be a 'feasibility study', which is a smaller study designed to see what works well before embarking on a larger project. During the study the investigators will collect clinical information and samples, such as blood, sputum and stool, from patients who come to hospital with a presumed respiratory infection or exacerbation of their chronic respiratory condition. The investigators will compare new diagnostic tests to traditional laboratory tests to understand their relative advantages and disadvantages for patient care.\n\nThis is a 'feasibility' study, a small study ran first to make sure things work properly before expanding to a much larger study.",[451,452,142,25,137,453],"Chronic Respiratory Conditions","COPD","Respiratory Exacerbation",[455],"ACCREDIT","2025-07-01",{"date":458,"type":30},"2025-07-04",{"date":456,"type":21},{"date":461,"type":21},"2026-04",{"name":463,"class":464},"Manchester University NHS Foundation Trust","OTHER_GOV",{"id":466,"slug":467,"hasResults":12,"nctId":468,"briefTitle":469,"officialTitle":469,"acronym":4,"eligibilityCriteria":470,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":471,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":473,"conditions":474,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":91},"100597314","monotherapy-vs-combination-therapy-for-bone-infections-caused-by-pseudomonas-aeruginosa-100597314","NCT07056881","Monotherapy vs Combination Therapy for Bone Infections Caused by Pseudomonas Aeruginosa","Inclusion Criteria:\n\n* Adult patients (≥18 years old)\n* Diagnosis of osteitis or osteomyelitis due to Pseudomonas aeruginosa\n* Isolation of Pseudomonas aeruginosa from at least one deep, sterile sample (e.g., bone biopsy, joint aspiration)\n* Imaging findings consistent with osteomyelitis (MRI, CT scan, or X-ray)\n\nExclusion Criteria:\n\n* No isolation of Pseudomonas aeruginosa\n* No imaging evidence suggestive of osteomyelitis\n* Patients under 18 years of age",{"count":472,"type":21},300,"This study looks at how well one antibiotic (monotherapy) works compared to two antibiotics (combination therapy) in treating bone infections caused by Pseudomonas aeruginosa. It includes 300 adult patients who had this type of infection confirmed by lab tests and medical imaging. The goal is to find out if using just one antibiotic is as effective as using two, while also looking at side effects, the need for more surgery, antibiotic resistance, and overall antibiotic use.",[475,476,477,25],"Osteomyelitis","Pseudomonas Infections","Pseudomonas Aeruginosa","2025-06-30",{"date":480,"type":30},"2025-07-09",{"date":482,"type":30},"2025-04-11",{"date":484,"type":21},"2026-04-15",{"name":486,"class":37},"Centre Hospitalier de Saint-Denis",{"id":488,"slug":489,"hasResults":12,"nctId":490,"briefTitle":491,"officialTitle":492,"acronym":493,"eligibilityCriteria":494,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":495,"targetDuration":4,"studyType":230,"phases":497,"briefSummary":498,"conditions":499,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":502,"lastUpdatePostDateStruct":503,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":341},"100524037","integrated-clinical-decision-support-for-empiric-antibiotic-selection-in-sepsis-100524037","NCT06103500","Integrated Clinical Decision Support for Empiric Antibiotic Selection in Sepsis","Integrated Clinical Decision Support for Empiric Antibiotic Selection in Sepsis: A Cluster Randomized Cross-Over Trial (IDEAS-CRXO)","IDEAS-CRXO","Inclusion Criteria:\n\n1. Admitted\n2. Age \\>18 years old\n3. Newly started (within 24 hours of assessment for eligibility) on at least one of the following antibiotic(s):\n\n   I. Vancomycin IV II. Linezolid III. Daptomycin IV. Clindamycin V. Cefazolin VI. Cloxacillin VII. Ceftriaxone VIII. Ceftazidime IX. Piperacillin-Tazobactam X. Meropenem (or Imipenem or Ertapenem) XI. Ciprofloxacin\n4. Blood cultures ordered (within 12 hours before or after initiation of index antibiotics).\n\nOverall Exclusion:\n\n1. Pregnancy\u002Fbreastfeeding\n2. Documented end-of-life (palliative) care and are\u002Fwill not be receiving ongoing antibiotic treatment.\n3. Already enrolled in the trial.\n4. Positive clinical culture results (those with speciation) for the index infection (within 72 hours) already available prior to assessment. Blood cultures with any Gram-positives will be an exclusion. Other cultures that are positive with a Gram-stain result but not speciation will not be an exclusion criteria.\n5. Explanatory molecular test (e.g. legionella urinary antigen test, sars-cov-2 testing) within 72 hours prior to assessment.\n6. Receipt of antimicrobials (not chronic suppression or prophylaxis) in the prior 24-72 hours (except if started in the outpatient setting or ED prior to admission in the 24-72 hours).\n7. The index prescription is a continuation of an antibiotic given for suppressive chronic therapy or long-standing treatment of an established infection.\n8. Index antibiotics are peri-operative only or ordered for \\\u003C24 hours.\n9. Cystic fibrosis.\n10. Known to be enrolled in a trial that dictates antimicrobial selection.\n11. Not eligible for any of the algorithms.",{"count":496,"type":21},1440,[266],"As antibiotic resistance increases globally, it becomes more difficult to select empiric antibiotic therapy, particularly in patients with sepsis who stand to benefit from early adequate treatment. In particular it is difficult for clinicians to balance antibiotic stewardship principles (the need to avoid unnecessary prescribing of antibiotics that have an excessively broad spectrum of activity that favour resistance development) and under treatment. The integration of multiple risk variables for resistance are hard for clinicians to translate into clinical action, and is seemingly at odds with the natural inclination to provide heuristic\u002Femotion-based antibiotic selection. The inappropriate treatment of sepsis is not uniformly too broad, or too narrow, and there is a need to optimize and tailor selection of antibiotic therapy to each patient, such that those that are at risk for resistant organisms receive broad therapy, and those that are not at risk, receive narrower antibiotic agents.\n\nClinicians need support picking the right antibiotic for each patient, and from this they can potentially drive reduction of unnecessarily broad antibiotic prescribing while preserving adequacy of treatment. Individualized clinical prediction models and decision support interventions are promising approaches that meet these needs by improving the classification of patient risk for antibiotic resistant or susceptible infections in sepsis. Unfortunately, few have been validated in the clinical setting and larger rigorous studies are needed to provide the evidence to support broader clinical adoption.\n\nThe investigators will perform a cluster randomized cross-over trial of an individualized antibiotic prescribing decision support intervention for providers treating hospitalized patients with suspected sepsis. The aim of this trial is to determine whether a stewardship led clinical decision support intervention can improve antibiotic de-escalation in patients with sepsis while maintaining or improving adequacy of antibiotic coverage. This decision support intervention will be based on a combination of proven decision heuristics (for Gram-positive organisms) and modelled predicted susceptibilities (for Gram-negative organisms) that are individualized to the patient. The primary outcome will be the proportion of patients de-escalated from their initial empiric regimen at 48 hours.",[143,25,500,501],"Community-Acquired Infections","Hospital Infection","2025-03-13",{"date":504,"type":30},"2025-03-17",{"date":506,"type":30},"2024-05-21",{"date":508,"type":21},"2025-10",{"name":510,"class":37},"Ottawa Hospital Research Institute",{"id":512,"slug":513,"hasResults":12,"nctId":514,"briefTitle":515,"officialTitle":515,"acronym":4,"eligibilityCriteria":516,"healthyVolunteers":12,"sex":17,"minAge":166,"maxAge":4,"enrollmentInfo":517,"targetDuration":518,"studyType":22,"phases":4,"briefSummary":519,"conditions":520,"keywords":523,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":531,"lastUpdatePostDateStruct":532,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":91},"100564881","international-surveillance-of-antimicrobial-resistance-in-cirrhosis-related-infections-100564881","NCT06634940","International Surveillance of Antimicrobial Resistance in Cirrhosis-Related Infections","Inclusion Criteria:\n\n* Episodes of culture-confirmed bacterial infections\n* Patients diagnosed with cirrhosis\n* Infections diagnosed either at the time of hospital admission or during hospitalization\n\nExclusion Criteria:\n\n* History of solid organ or hematopoietic stem cell transplantation\n* Declined to participate in the study",{"count":75,"type":21},"1 Week","What is this study about?\n\nThis study tracks antibiotic resistance in patients with cirrhosis who develop bacterial infections. Cirrhosis is a condition where the liver is severely scarred, and people with cirrhosis are at high risk for serious bacterial infections.\n\nWhy is this study important?\n\nBacterial infections are common in patients with cirrhosis, affecting 25-46% of those who are hospitalized. These infections can be life-threatening, with 1 in 4 patients dying from complications. Many of these infections are becoming harder to treat because the bacteria are resistant to antibiotics. Infections caused by resistant bacteria are increasing, which makes finding the right antibiotic quickly even more difficult.\n\nIn other regions of the world, guidelines exist to help doctors choose the right antibiotics for cirrhosis patients. However, in Latin America, we don't have specific guidelines for our region, and doctors currently rely on recommendations from the U.S. or Europe. These guidelines may not reflect the local patterns of bacterial infections and resistance we see here.\n\nWhat is the goal of this study?\n\nThe main goal of this study is to create a long-term system to track how bacteria respond to antibiotics in patients with cirrhosis in Latin America. By collecting data from hospitals across different countries, we aim to:\n\n* Identify how many infections are caused by multidrug-resistant bacteria.\n* Understand how antibiotics (such as ceftriaxone, vancomycin, and carbapenems) act against these infections.\n* Generate reports informing bacterial resistance patterns to help doctors make better patient treatment decisions.\n\nWhat do we hope to achieve?\n\nWe hope the data we collect will help develop guidelines for patients with cirrhosis in Latin America. These guidelines will ensure that doctors use the most effective antibiotics based on real-time data from our region. This should improve patient outcomes and help prevent the spread of resistant bacteria.",[521,25,522],"Cirrhosis","Multidrug Resistance",[180,524,525,526,527,528,529,530],"empirical treatment","methicillin-resistant Staphylococcus aureus","extended-spectrum beta-lactamase-producing organisms","Carbapenemase-Producing Enterobacteriaceae","de-escalation","guidelines","empiric antibiotics","2024-10-08",{"date":533,"type":30},"2024-10-10",{"date":535,"type":30},"2020-11-15",{"date":537,"type":21},"2031-06-01",{"name":539,"class":37},"Hospital Italiano de Buenos Aires",{"id":541,"slug":542,"hasResults":12,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":4,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":230,"phases":549,"briefSummary":550,"conditions":551,"keywords":553,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":91},"100563759","a-cluster-randomized-controlled-trial-to-compare-the-rate-of-antibiotic-infusion-100563759","NCT06620341","A Cluster Randomized Controlled Trial to Compare the Rate of Antibiotic Infusion","Comparing the Rate of Antibiotic Infusion Among Patients with Acute Upper Respiratory Tract Bacterial Infections in the Emergency Department -- a Cluster Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients with upper respiratory tract infections seeking emergency medical attention;\n\n  * Patients with laboratory tests indicating White Blood Cell (WBC) \\>10×10\\^9\u002FL or White Blood Cell (CRP) ≥ 10.0mg\u002FL, requiring the use of antimicrobial agents;\n\n    * Patients aged ≥ 18 years; ④ Patients with at least one of the following local signs and symptoms: (1) fever, (2) cough, (3) rhinitis (sneezing, nasal congestion, or rhinorrhea), (4) pharyngitis (sore throat), (5) shortness of breath, (6) wheezing, (7) chest pain, (8) abnormal auscultation findings.\n\nExclusion Criteria:\n\n* Patients with other infections in addition to upper respiratory tract infections; ② Patients who require hospitalization or treatment in a higher-level medical institution as assessed by medical professionals;\n\n  * Patients who cannot take oral medications or have severe gastrointestinal dysfunction; ④ Special patients, including those with neutropenia, bone marrow suppression, during radiochemotherapy, undergoing immunosuppressive therapy, human immunodeficiency virus (HIV)-positive patients, patients with congenital immune deficiency, pregnant patients, and patients with mental illnesses.",{"count":548,"type":21},11900,[266],"Acute upper respiratory tract infection, commonly known as upper respiratory infection, is an acute inflammation primarily affecting the nose, pharynx, or larynx caused by various viruses and\u002For bacteria. Viruses are more common, accounting for 70% to 80% of cases, while bacterial infections account for 20% to 30%. For a long time, the high rate of intravenous infusion use has been a prominent issue in clinical diagnosis and treatment in China. The irrational and excessive use of antimicrobials in emergency patients with upper respiratory tract bacterial infections has also become increasingly apparent, imposing unnecessary financial burdens and risks of drug side effects on patients. Therefore, reducing the rate of intravenous antimicrobial administration in emergency patients with upper respiratory tract bacterial infections has become an urgent problem to be solved. By implementing measures such as health education by clinical pharmacists and enhancing the awareness of rational antimicrobial use in doctors, it is expected to lower the rate of intravenous antimicrobial administration, reduce the occurrence of drug resistance, improve treatment convenience for patients, and lower treatment costs while ensuring therapeutic efficacy.\n\nThe purpose of this study was to investigate whether clinical pharmacists can reduce the intravenous infusion rate of antimicrobials in emergency patients with upper respiratory tract bacterial infections through medication education for emergency medical staff and to observe whether this intervention will affect the prognosis and medication safety of these patients.",[552,25],"Acute Upper Respiratory Tract Infection",[554,555,556],"Bacterial infection of upper respiratory tract","Infusion rate","pharmacist","2024-09-29",{"date":559,"type":30},"2024-10-01",{"date":561,"type":21},"2024-11-18",{"date":563,"type":21},"2025-04-30",{"name":565,"class":37},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":567,"slug":568,"hasResults":12,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":572,"eligibilityCriteria":573,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":574,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":575,"conditions":576,"keywords":588,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":604,"lastUpdatePostDateStruct":605,"startDateStruct":606,"completionDateStruct":608,"leadSponsor":610,"locationsCount":264},"100284234","fosfomycin-iv-for-treatment-of-severely-infected-patients-100284234","NCT02979951","Fosfomycin I.v. for Treatment of Severely Infected Patients","An International, Multicentre, Non-comparative, Non-interventional, Prospective Clinical Registry to Evaluate the Clinical Outcome and Safety of the Treatment of Severely Infected Patients with Fosfomycin I.v.","FORTRESS","Inclusion Criteria:\n\n* Male or female patients aged ≥ 18 years\n* Treatment with fosfomycin according to the (national) Summary of Product Characteristics (SmPC) of fosfomycin i.v.\n* Patients with osteomyelitis, complicated urinary tract infection, nosocomial lower respiratory tract infection, bacterial meningitis\u002Fcentral nervous system infection, bacteraemia\u002Fsepsis, skin and soft tissue infection, endocarditis or other infection, each as far as covered by the respective nationally relevant SmPC\n* Written informed consent of the participant (or person in charge in case of patients incapable of giving consent)\n\nExclusion Criteria:\n\n* Previous documentation of the patient in the present study\n* Patients participating in an interventional clinical trial\n* Patients with known hypersensitivity to fosfomycin or any of the excipients\n* Terminally ill patients\n* Patients with \"do not resuscitate order\"\n* Palliative treatment approach\n* Failure of \\> 3 of the following organ systems: respiratory system, nervous system, cardiovascular system, liver, coagulation, kidney\n* Manifest Human Immunodeficiency Virus (HIV) disease (Acquired Immunodeficiency Syndrome, AIDS)\n* Fosfomycin treatment as 4th line treatment or at later stage\n* Patients with involvement of fungi or mycobacteria in the targeted infection",{"count":75,"type":21},"The purpose of this European, multicentric, prospective, non-interventional study is to document and evaluate the efficacy and safety of the treatment of severely infected patients with intravenously administered fosfomycin, including patients with osteomyelitis, complicated urinary tract infection, nosocomial lower respiratory tract infection, bacterial meningitis\u002Fcentral nervous system infection, bacteraemia\u002Fsepsis, skin and soft tissue infection, endocarditis or other infections, each as far as covered by the respective nationally relevant SmPC.",[25,577,475,578,579,580,581,400,402,582,583,584,585,143,586,587],"Bone Diseases, Infectious","Central Nervous System Bacterial Infections","Meningitis, Bacterial","Encephalitis","Brain Abscess","Pneumonia, Bacterial","Skin Diseases, Bacterial","Soft Tissue Infections","Intraabdominal Infections","Bacteremia","Endocarditis, Bacterial",[589,590,591,592,593,594,595,596,597,598,25,599,600,577,475,578,579,580,581,400,402,582,583,584,585,143,586,587,601,602,603,331],"Observational Study","Non-Interventional Study","Registries","Prospective","Monitored","Multicentric","International","Fosfomycin","Infectofos","Fomicyt","Gram-Negative Bacterial Infections","Gram-Positive Bacterial Infections","Treatment Outcome","Clinical Efficacy","Microbiological Efficacy","2024-09-27",{"date":559,"type":30},{"date":607,"type":4},"2016-12",{"date":609,"type":21},"2030-12",{"name":611,"class":66},"Infectopharm Arzneimittel GmbH",{"id":613,"slug":614,"hasResults":12,"nctId":615,"briefTitle":616,"officialTitle":617,"acronym":618,"eligibilityCriteria":619,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":620,"targetDuration":4,"studyType":230,"phases":622,"briefSummary":624,"conditions":625,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":627,"lastUpdatePostDateStruct":628,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":632,"locationsCount":91},"100499469","phase-4-trial-comparing-conventional-antibiotic-strategies-versus-regimens-guided-by-epidemiological-surveillance-in-infected-patients-with-cirrhosis-survicstudy-100499469","NCT05783661","Trial Comparing Conventional Antibiotic Strategies Versus Regimens Guided by Epidemiological Surveillance in Infected Patients With Cirrhosis (SURVIC_STUDY)","Randomized Controlled Trial Comparing Conventional Antibiotic Strategies Versus Regimens Guided by Epidemiological Surveillance in Infected Patients With Cirrhosis","SURVIC","Inclusion Criteria:\n\n1. Cirrhotic patients with acute decompensation aged ≥18 years.\n2. Proven or suspected bacterial infection requiring antibiotic therapy (diagnosis will be established according to local guidelines, Appendix 1).\n3. Signed informed consent or consent given by their legal representatives or close relatives.\n\nExclusion Criteria:\n\n1. Bacterial infection lasting for \\> 48 hours.\n2. Infection in a critically ill cirrhotic patient (ICU admission). In this population, epidemiological surveillance is standard clinical practice.\n3. Evidence of current locally advanced or metastatic malignancy (patients with hepatocellular carcinoma within the Milan criteria and non-melanocytic skin cancer can be included).\n4. Pregnant and\u002For breast-feeding woman.\n5. Patients who cannot provide prior informed consent and when there is documented evidence that the patient has no legal surrogate decision-maker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent.",{"count":621,"type":21},198,[623],"PHASE4","Study to comparing conventrional antibiotic strategies versus regimens guided by epidemiological surveillance in infected patients with cirrhosis.",[626,25],"Decompensated Cirrhosis","2024-09-26",{"date":604,"type":30},{"date":630,"type":30},"2023-12-11",{"date":217,"type":21},{"name":633,"class":37},"Eva Bonfill",{"id":635,"slug":636,"hasResults":12,"nctId":637,"briefTitle":638,"officialTitle":639,"acronym":640,"eligibilityCriteria":641,"healthyVolunteers":12,"sex":17,"minAge":642,"maxAge":166,"enrollmentInfo":643,"targetDuration":4,"studyType":230,"phases":645,"briefSummary":646,"conditions":647,"keywords":648,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":654,"lastUpdatePostDateStruct":655,"startDateStruct":657,"completionDateStruct":659,"leadSponsor":661,"locationsCount":663},"100466214","impact-of-procalcitonin-guided-algorithm-on-early-discontinuation-of-antibiotic-therapy-100466214","NCT05350813","Impact of Procalcitonin-guided Algorithm on Early Discontinuation of Antibiotic Therapy","Impact of Procalcitonin-guided Algorithm on Early Discontinuation of Antibiotic Therapy in Pediatric Intensive Care Units : a Multicenter Randomized Controlled Trial","PRODISCO","Inclusion Criteria:\n\n* Neonates, infants and children hospitalized in Pediatric and Neonatal ICU and receiving intravenous antibiotics for less than 24 hours for an episode of suspected or proven community-acquired or nosocomial bacterial infection.\n* Written informed consent signed by both parents or legal guardians.\n* Affiliated to a social security scheme.\n* Parents French-speaking.\n\nExclusion Criteria:\n\n* Newborns \\\u003C72 hours old.\n* Neonates \\\u003C37 weeks postmenstrual age.\n* Age ≥18 years.\n* Pregnant or breastfeeding women.\n* Patients with cystic fibrosis.\n* Immunocompromised patients including patients with hereditary immunodeficiency, agranulocytosis (neutrophils count \\\u003C500\u002Fmm3), HIV infection with CD4 count \\\u003C200\u002Fmm3, sickle cell disease, those who have undergone splenectomy, those who have a history of solid organ or hematopoietic stem cell transplant, those with hemopathy or solid organ tumor treated with chemotherapy, and those on immunosuppressive drugs including systemic corticosteroids taken daily for at least 15 days prior to Day 0.\n* Inflammatory situations increasing PCT plasma concentrations in the absence of infection: burns, extracorporeal membrane oxygenation (ECMO), first 48 hours following an open-heart cardiac surgery with cardiopulmonary bypass.\n* Infections requiring prolonged antibiotic therapy: infected thrombophlebitis, infective endocarditis, mediastinitis, abscess or empyema (e.g. peritonsillar abscess, retropharyngeal abscess, adenophlegmon, retroauricular abscess, retroorbital abscess, pulmonary abscess, pleural empyema, liver abscess, splenic abscess, brain abscess, subdural empyema, extradural empyema, epidural abscess, intramuscular abscess), necrotizing dermohypodermitis or necrotizing fasciitis, osteomyelitis, osteitis, arthritis, spondylodiscitis, prostatitis, tuberculosis, meningitis except those caused by Haemophilus and Meningococcus, infection on a device excluding intravascular catheter, endotracheal tube, tracheostomy, and urinary catheter.\n* Antibiotic for prophylaxis.\n* Children previously included in an interventional study in progress.","3 Days",{"count":644,"type":21},296,[266],"In this randomized controlled open-label trial, conducted in 7 French Pediatric and Neonatal Intensive Care Units (ICUs), investigator team hypothesize that the use of a procalcitonin (PCT)-guided algorithm to discontinue antibiotic treatment will decrease antibiotic duration in critically ill children treated for a suspected or proven bacterial infection. Two hundred and ninety-six eligible patients will be randomly assigned in two groups: either PCT-guided or standard-of-care antibiotic discontinuation, and monitored over 28 days, until the end of their hospitalization, or up to the end of antibiotic treatment for bacterial infection recurrence occurring up to 28 days after the day of randomization.",[25],[649,650,651,652,653],"procalcitonin","Children","Pediatric Intensive Care Unit","Procalcitonin-guided antibiotic therapy","Algorithm","2024-09-23",{"date":656,"type":30},"2024-09-25",{"date":658,"type":30},"2023-05-02",{"date":660,"type":21},"2027-02-02",{"name":662,"class":37},"University Hospital, Toulouse",7,{"id":665,"slug":666,"hasResults":12,"nctId":667,"briefTitle":668,"officialTitle":668,"acronym":4,"eligibilityCriteria":669,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":670,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":672,"conditions":673,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":674,"lastUpdatePostDateStruct":675,"startDateStruct":677,"completionDateStruct":679,"leadSponsor":681,"locationsCount":91},"100558670","development-and-evaluation-of-ai-program-for-predicting-bacterial-species-from-urine-gram-stain-specimens-100558670","NCT06554145","Development and Evaluation of AI Program for Predicting Bacterial Species From Urine Gram Stain Specimens","Inclusion Criteria:\n\n* Specimens for which urine culture and urine Gram staining tests were performed for clinical purposes\n\nExclusion Criteria:\n\n* Samples for which suspension of use has been requested",{"count":671,"type":21},15000,"The purpose of this research is to develop an AI that estimates bacterial species from Gram staining images of urine specimens, and to evaluate the accuracy and labor reduction effect of Gram staining Automation system equipped with this AI.",[25],"2024-08-13",{"date":676,"type":30},"2024-08-15",{"date":678,"type":30},"2023-09-25",{"date":680,"type":21},"2028-08",{"name":682,"class":66},"GramEye",{"id":684,"slug":685,"hasResults":12,"nctId":686,"briefTitle":687,"officialTitle":687,"acronym":4,"eligibilityCriteria":688,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":689,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":691,"conditions":692,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":693,"lastUpdatePostDateStruct":694,"startDateStruct":696,"completionDateStruct":698,"leadSponsor":700,"locationsCount":91},"100555972","development-and-evaluation-of-rapid-bacterial-species-identification-for-acid-fast-bacilli-smear-using-image-analysis-ai-100555972","NCT06519032","Development and Evaluation of Rapid Bacterial Species Identification for Acid-Fast Bacilli Smear Using Image Analysis AI","Inclusion Criteria:\n\n* Patients in whom acid-fast bacilli(AFB) smear test was ordered\n\nExclusion Criteria:\n\n* No exclusion criteria",{"count":690,"type":21},10000,"The goal of this observational study is to develop AI that detects and classifies Acid-Fast Bacilli from microscope images using anonymized and fixed glass slides.",[25],"2024-07-24",{"date":695,"type":30},"2024-07-26",{"date":697,"type":30},"2023-09-20",{"date":699,"type":21},"2027-03",{"name":682,"class":66}]