[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:infection":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,47,0,25,[9,47,72,100,132,164,189,219,252,272,299,321,353,378,415,440,469,497,524,551,576,613,633,658,684],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100616741","the-extended-study-of-prevalence-of-infection-in-intensive-care-iv-100616741",false,"NCT07309549","The Extended Study of Prevalence of Infection in Intensive Care IV","The Extended Study of Prevalence of Infection in Intensive Care IV (EPIC IV)","EPIC IV","Inclusion Criteria:\n\n* All adult patients (\\>18 years) treated in the participating ICUs on the study day.\n\nExclusion Criteria:\n\n* Patients under 18 years","ALL","18 Years",{"count":21,"type":22},10000,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn how common infections are in intensive care units (ICUs) around the world and how they are treated. The study will look at all adults in the ICU during a single 24-hour period. The main questions it aims to answer are:\n\n* What types of infections and antibiotic-resistant bacteria are most common in ICUs worldwide?\n* How do resistance patterns affect how participants are treated and how they recover?\n\nHow are antibiotics used in ICUs, and how do hospitals practice antibiotic stewardship?\n\n* What organ support treatments do participants with infections receive?\n* What are the outcomes of participants with severe infections, including survival at hospital discharge (up to 60 days)?\n\nResearchers will compare ICUs across regions and income levels to see how infection patterns, treatments, and outcomes differ around the world.\n\nParticipants will:\n\n* Be counted if they are present in the ICU at any time during the study day.\n* Have information collected from their medical record about their health, the infection they may have, treatments they receive, and their outcome at ICU and hospital discharge (up to 60 days).\n\nBecause this is an observational study, participants will not receive any new treatments as part of the study.",[26,27],"Sepsis","Infection",[29,30,31,32,33,34],"Intensive Care Unit","Critical Illness","Severe Infection","Organ Dysfunction","ICU Outcomes","Global Prevalence","NOT_YET_RECRUITING","2026-06-24",{"date":38,"type":39},"2026-06-29","ACTUAL",{"date":41,"type":22},"2027-02-01",{"date":43,"type":22},"2027-06",{"name":45,"class":46},"Universidad de la Sabana","OTHER",{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":18,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":4,"leadSponsor":68,"locationsCount":71},"100099544","diagnosis-and-management-of-inflammatory-and-infectious-diseases-100099544","NCT00557726","Diagnosis and Management of Inflammatory and Infectious Diseases","* INCLUSION CRITERIA:\n\n  1. Known or suspected exposure to infection, as determined by the Principal Investigator OR Presence of signs and symptoms of an infectious or inflammatory disease\n  2. Age range: 3 years of age and older.\n  3. NIAID\u002FLIR investigator who has an interest in the patient s illness and is willing to serve as attending physician to supervise the patient's medical care at the NIH.\n  4. Primary physician outside the NIH\n  5. The patient or the patient's Legally Authorized Representative is capable of informed consent and signs the consent form. The consent form will be signed by parents or guardians of patients under the age of 18\n\nEXCLUSION CRITERIA:\n\n1. Pregnant.\n2. Presence of conditions that, in the judgment of the investigator, may put the participant at undue risk or make them unsuitable for participation in the study.","3 Years","100 Years",{"count":56,"type":22},400,"This protocol is being established to cover the evaluation of patients with inflammatory and\u002For infectious diseases which are not covered under previously existing protocols. The purpose of such a protocol is that frequently patients are referred to us with either diagnosed or undiagnosed illnesses which would be of interest to our teaching program or which would serve as a source of patients to subsequently be entered into established, ongoing protocol studies. Such patients will be admitted to the protocol and handled according to accepted medical practice of diagnosis and treatment.",[27,59],"Inflammation",[59,27,61,62],"Fever","Natural History","RECRUITING",{"date":65,"type":39},"2026-06-25",{"date":67,"type":39},"1978-02-17",{"name":69,"class":70},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",1,{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":79,"minAge":19,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":71},"100453852","phase-1-nadph-oxidase-correction-in-mrna-transfected-granulocyte-enriched-cells-in-chronic-granulomatous-disease-cgd-100453852","NCT05189925","NADPH Oxidase Correction in mRNA-transfected Granulocyte-enriched Cells in Chronic Granulomatous Disease (CGD)","NADPH Oxidase Correction in mRNA Transfected Granulocyte-enriched Cells in Chronic Granulomatous Disease (CGD)","* INCLUSION CRITERIA:\n\nIndividuals must meet all of the following criteria to be eligible for study participation:\n\n* Males aged 18 to 75 years\n* CGD confirmed by DHR and deficiency subtype confirmed by protein analysis and\u002For genetic sequencing\n* Has a physician at home for follow-up care\n* Able to provide informed consent\n* For men who engage in activities that can result in pregnancy, agree to use contraception when engaging in sexual activities that can result in pregnancy. Contraception must be used from screening through 3 months after the CGD-Grans infusion. Acceptable methods of contraception include the following:\n\n  * Hormonal contraception\n  * Male or female condom\n\nEXCLUSION CRITERIA:\n\nIndividuals meeting any of the following criteria will be excluded from study participation:\n\n* Clinically unstable due to moderate to severe acute systemic infections as defined by persistent resting tachypnea, tachycardia, or hypoxia of \\>20% from baseline and hypotension.\n* Current or history of stage 4 chronic kidney disease or estimated glomerular filtration rate \\[eGFR\\] \\\u003C30 mL\u002Fmin\u002F1.73 m\\^2 within 90 days of baseline.\n* Unstable diabetes mellitus with hemoglobin A1c \\>7.0% and fasting serum glucose \\>200 mg\u002FdL at screening.\n* Current or history of heart failure stage D as defined by the American College of Cardiology Foundation\u002FAmerican Heart Association guidelines.\n* History of arrhythmias that are symptomatic and deemed clinically unsafe for participation by NIH CC Cardiology consultation.\n* Current or history of invasive cancers that require chemotherapy within 5 years of screening.\n* Active hepatitis B, C, or HIV infections at screening.\n* Unstable hypertension requiring addition of new anti-hypertensives within 2 weeks of screening.\n* Impaired renal function that is unstable, with serum creatinine \\>3.0 mg\u002FdL and rising.\n* Serum transaminases and bilirubin that are \\>3 x the upper limit of normal.\n\nNOTE: For prospective subjects who, per PI assessment at screening, have abnormal liver function tests, and\u002For a significant history of liver disease, and\u002For liver-related complications of CGD, and who otherwise meet eligibility criteria \\[i.e. those who do NOT meet any of the exclusion set forth herein\\], a hepatology consult will be required at screening, and participation must be approved in writing by hepatology to the PI.\n\n* Electrocardiogram abnormalities indicative of acute myocardial injury, or arrhythmias that presents anesthetic risks, at screening.\n* Anemia with hemoglobin \\\u003C8 g\u002FdL (transfusions to correct anemia permitted).\n* Thrombocytopenia (platelets \\\u003C50 x10\\^9 cells\u002FL) (platelet transfusions to correct thrombocytopenia permitted).\n* Profound thrombocytopenia (platelet counts \\\u003C10,000\u002Fmicroliter) that is not reversible with platelet transfusions.\n* Abnormal prothrombin time\u002Fpartial thromboplastin time (PT\u002FPTT) values outside the ranges accepted at the NIH CC that are not corrected or that cannot be attributed to presence of Lupus anticoagulant (commonly found in CGD patients).\n* Inherited bleeding disorder that precludes line placement.\n* Severe oxygen-dependent pulmonary disease that increases risks of procedures that may require sedation.\n* History of or current evidence of alcohol or illicit drug abuse or dependence.\n* Participation in a clinical protocol that includes an intervention that, in the opinion of the investigator, may affect the results of the current study.\n\nSubjects will be selected in an equitable manner from the available pool of potentially eligible individuals, without regard to factors such as gender, race, ethnicity, socioeconomic status, etc, except for age and sex.","MALE","75 Years",{"count":7,"type":22},"INTERVENTIONAL",[84],"PHASE1","Background:\n\nCGD is caused by a gene mutation. For people with CGD, their cells cannot kill germs well, so they can get frequent or life-threatening infections. Researchers want to see if a new procedure can help a person s cells kill germs for a short time. It uses messenger RNA (mRNA) to deliver correct instructions for the gene mutation to the cells.\n\nObjective:\n\nTo test a procedure in which mRNA is added to a person s blood cells.\n\nEligibility:\n\nMales aged 18-75 with CGD with a mutation in the gene that makes the protein gp91phox.\n\nDesign:\n\nParticipants will be screened with:\n\nMedical history\n\nPhysical exam\n\nBlood and urine tests\n\nSwab to test for strep throat\n\nSome screening tests will be repeated during the study.\n\nParticipants will be admitted to the NIH Clinical Center hospital for at least 7 days. They will have apheresis. For this, a medicine is injected under their skin to prepare their white blood cells for collection. An IV line is placed into an arm vein. Blood goes through the IV line into a machine that divides whole blood into red blood cells, plasma, and white blood cells. The white blood cells are removed, and the rest of the blood is returned to the participant through an IV line in their other arm. The next day, they will get their mRNA-corrected cells via IV. They will be monitored for 3 more days.\n\nAfter discharge, participants will keep a symptom diary. They will be contacted weekly for one month, and then once a month. They will have a follow-up visit 3 months after the infusion.",[87,27],"Chronic Granulomatous Disease",[89,90,91,92],"Primary Immune Deficiency","systemic infection","autologous transfusion","Apheresis","2026-06-23",{"date":36,"type":39},{"date":96,"type":39},"2022-07-22",{"date":98,"type":22},"2026-07-01",{"name":69,"class":70},{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":82,"phases":109,"briefSummary":111,"conditions":112,"keywords":116,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":71},"100644116","phase-3-naproxen-versus-placebo-as-adjunct-treatment-of-cellulitis-a-randomized-controlled-trial-100644116","NCT07665476","Naproxen Versus Placebo as Adjunct Treatment of Cellulitis: A Randomized Controlled Trial","NVP","Inclusion Criteria:\n\n* adults (age ≥18 years) diagnosed with cellulitis and determined by the treating physician to be eligible for outpatient treatment with oral cephalexin.\n\nExclusion Criteria:\n\n* These are appropriate exclusions according to eligibility for treatment with naproxen in clinical practice, and we believe that relatively few patients will be excluded. We will exclude participants for any of the following reasons: (a) Age \\\u003C18 years; (b) Patient already taking oral antibiotics or NSAIDs; (c) Treating physician decides IV antibiotics are required; (d) Skin abscess requiring incision and drainage; (e) Known prior skin or soft tissue infection secondary to methicillin-resistant Staphylococcus aureus (MRSA); (f) Cellulitis secondary to a human or animal bite; (g) Penetrating wound or water exposure resulting in cellulitis; (h) Surgical site infection; (i) Pregnancy or breastfeeding; (j) Prior gastric bypass surgery; (k) Patients on dual antiplatelet therapy; (l) Patients on warfarin, low molecular weight heparin, or direct oral anticoagulant therapy; (m) Severe uncontrolled heart failure, or coronary artery bypass grafting (CABG) surgery within 14 days prior to the index visit, or planned CABG surgery within 21 days following the index visit.; (n) History of gastric\u002Fduodenal ulcer or gastrointestinal bleeding in the past 12 months; (o) Known kidney impairment with an estimated glomerular filtration rate \\\u003C30 mL\u002Fmin documented on the electronic health record at any time within the past three months; (p) Known hyperkalemia documented on the electronic health record at any time within the past three months; (q) Liver cirrhosis; (r) Inflammatory bowel disease; (s) History of asthma, urticaria or allergic reactions after taking NSAIDs or aspirin; (t) Allergy to cephalosporins or history of anaphylaxis to penicillin; (u) Inability to provide informed consent.\n\nExclusion criteria (i) through (s) are known contraindications to NSAIDs.",{"count":108,"type":22},884,[110],"PHASE3","Cellulitis is a painful bacterial skin infection commonly seen in Canadian emergency departments. Cellulitis has a negative impact on patients' quality of life and productivity. While this is a bacterial infection, there is evidence inflammation also contributes to the disabling symptoms of pain, redness and swelling. Some studies have suggested that a nonsteroidal anti-inflammatory drug (NSAID) such as naproxen in addition to antibiotics may control inflammation and speed recovery. However, these studies have had too few patients to tell if there is a true benefit.\n\nThe investigators are proposing a randomized controlled trial of patients with cellulitis to compare oral naproxen (500 mg twice daily) plus oral antibiotics versus placebo plus oral antibiotics. The investigators will compare the proportion of patients who have an early clinical response (reduction in area of redness ≥20% at 72 hours), cure, treatment failure, adverse events, and hospital admission.\n\nIf naproxen proves to be superior to placebo, this simple, low-cost intervention will speed time to recovery with less pain for patients, and may potentially reduce treatment failure and time missed from activities. The results of this trial will help inform future cellulitis treatment guidelines.",[113,114,27,115],"Cellulitis","Skin Disease, Infectious","Skin and Soft Tissue Infections (SSTIs)",[117,118,113,119,120,121,122,123],"Infectious Diseases","Emergency Medicine","naproxen","antibiotics","oral antibiotics","cephalexin","anti-inflammatories","2026-06-18",{"date":36,"type":39},{"date":127,"type":22},"2026-09-01",{"date":129,"type":22},"2031-12-01",{"name":131,"class":46},"Ottawa Hospital Research Institute",{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":82,"phases":141,"briefSummary":143,"conditions":144,"keywords":147,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":159,"leadSponsor":161,"locationsCount":163},"100641892","automated-insulin-delivery-versus-daily-injections-for-hospital-diabetes-care-100641892","NCT07645079","Automated Insulin Delivery Versus Daily Injections for Hospital Diabetes Care","Inpatient Diabetes Management With Automated Insulin Delivery Systems Compared to Multiple Daily Injections With a Basal-bolus Regimen - a Randomized Controlled Trial","Inclusion Criteria:\n\n* A documented history of Type 2 diabetes mellitus (T2DM) which requires subcutaneous insulin therapy\n* acute infectious disease of any kind\n* age ≥ 18 years old\n* willingness and ability to comply with theclinical investigation plan\n* ability to communicate with the trial personal\n* an expected length of hospital stay for at least 2 days after enrolment\n\nExclusion Criteria:\n\n* Patients already using AID for their glycemic management\n* Patients in use of an insulin pump\n* Skin pathologies that hinder application of a FreeStyle Libre-3 CGM and mylife YpsoPump\n* Participation in another trial, which could influence the outcome of the trial\n* Any mental condition rendering the patient incapable of giving informed consent\n* Known or suspected allergy to adhesive material\u002Ftape of the Libre-3-sensor and\u002For YpsoPump\n* Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient\n* Diagnoses\u002Ftreatments\u002Fclinical parameters prohibiting use of Insulin\u002FAID such as\n\n  * Estimated glomerular filtration rate (eGFR) \\\u003C15 mL\u002Fmin\u002F1.73 m2 OR\n  * Treated with hydroxyurea\u002Fhydroxycarbamide OR\n  * Nutritional therapy (continuous enteral or parenteral feeding) OR\n  * Clinically relevant pancreatic disease OR\n  * Aystemic glucocorticoid treatment with prednisone equivalent dose \\>5 mg\u002Fday OR\n  * Expected to require admission to the intensive-care unit OR \\> Patients in dialysis",{"count":140,"type":22},92,[142],"NA","Aim\n\nThe investigators aim to investigate if automated insulin delivery systems (AID) improve in-hospital glycemic and clinical outcomes in patients with type 2 diabetes compared to standard-of-care with a pen-basal-bolus insulin regimen manually titrated by general staff at Herlev-Gentofte Hospital and a clinical decision support system (GlucoTab) titrating the basal-bolus regimen automatically daily at Graz University Hospital.\n\nPopulation\n\nHospitalized patients with type 2 diabetes in non-intensive care units (non-ICU) at medical wards at Copenhagen University Hospitals of Herley-Gentofte (affiliated with Steno Diabetes Center Copenhagen) and Medical University Hospital of Graz (N = 92).\n\nDesign\n\nThis is an investigator-initiated, two-armed, two-site, prospective, randomized, open-label, blinded endpoint (PROBE) trial.\n\nObjectives\n\nThe objective is to determine the glycemic and clinical effects of inpatient AID systems in non-ICU patients with type 2 diabetes. Participants will be randomized in a usual-of-care and an AID arm. Diabetes management will be performed by usual care in the control arm based on a basal-bolus insulin regimen and point-of-care (POC) glucose testing. A continuous glucose monitoring (CGM) system (Abbott FreeStyle Libre 3) will be used in all groups for outcome analysis and comparison between the groups. The CGM will be blinded for the control arm, to not interfere with the usual of care because of the higher amount of glucose data. The AID-arm will be managed by an AID system with real-time CGM data transmitted to nursing stations.\n\nOutcomes\n\nPrimary outcome: The primary outcome is the difference in CGM-recorded time in range (TIR) (70-180 mg\u002Fdl (3.9-10.0 mmol\u002Fl)) between the POC- and the CGM-arm according to the 2023 in-hospital CGM consensus during the entire hospital stay.\n\nSecondary outcomes: Outcomes are reported according to the 2023 in-hospital CGM consensus and specified in the protocol during the entire hospital stay, including three levels of time above range (TAR) 180-250mg\u002Fdl (10.0-13.9 mmol\u002Fl), \\>250mg\u002Fdl (\\>13.9 mmol\u002Fl), and \\>180mg\u002Fdl (\\>10.0 mmol\u002Fl); three levels of time below range (TBR) 54-70mg\u002Fdl (3.0-3.9 mmol\u002Fl), \\\u003C54mg\u002Fdl (\\\u003C3.0 mmol\u002Fl), and \\\u003C70mg\u002Fdl (\\\u003C3.9 mmol\u002Fl); events of hypoglycemia in three levels, 54-68mg\u002Fdl (3.0-3.8 mmol\u002Fl), \\\u003C54mg\u002Fdl (\\\u003C 3.0 mmol\u002Fl), and \\\u003C70mg\u002Fdl (\\\u003C3.9 mmol\u002Fl), where the glucose values between the two hypoglycemic events must all be \\>70mg\u002Fdl (\\>3.9 mmol\u002Fl) for at least 15 consecutive minutes(1), including prolonged hypoglycemic events (\\> 120 minutes), recurrent hypoglycemic events (events preceded by another hypoglycemic event), and recurrent hypoglycemic days (percentage of days with at least one hypoglycemic event on separate days that is preceded by another in-hospital day with hypoglycemia(1)); mean glucose level; standard deviation (SD) of the CGM glucose distribution; coefficient of variation (CV); and insulin doses during hospitalization.\n\nClinical outcomes: The investigator assess the length of hospital stay as calculated from time of admission until discharge; in-hospital mortality; admissions to intensive care unit; any in-hospital-related complications occurring at least one day after randomization and until discharge, as documented and defined by the treating physician in the electronic health record (e.g., acute kidney injurie, sepsis, etc.)\n\nMethod\n\nFor the usual-of-care-arm, glucose assessment is done by standard POC glucose testing and insulin is manually titrated by general staff at Herlev-Gentofte Hospital and the glucose assessment is done by standard POC glucose testing and insulin is manually titrated by the GlucoTab system titrating the basal-bolus regimen automatically daily at Graz University Hospital. For the AID-arm, CGM data informs in real time the mylife Ypsopump for automated insulin delivery.\n\nDevice\n\nThe investigational device is the AID system, containing of the mylife YpsoPump and the FreeStyle Libre 3 sensor.",[145,27,146],"Diabetes Mellitus Type 2","CGM",[148,149,146,150,151,152,153,154],"automated insulin delivery systems","AID","continouse glucose monitoring","infectiouse disease","type 2 diabetes mellitus","diabetes mellitus type 2","GlucoTab","2026-06-08",{"date":157,"type":39},"2026-06-12",{"date":98,"type":22},{"date":160,"type":22},"2027-07-30",{"name":162,"class":46},"Steno Diabetes Center Copenhagen",2,{"id":165,"slug":166,"hasResults":12,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":174,"conditions":175,"keywords":176,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":184,"leadSponsor":186,"locationsCount":188},"100638206","multicenter-validation-of-a-risk-prediction-model-for-mdrgnb-infection-100638206","NCT07603128","Multicenter Validation of a Risk Prediction Model for MDRGNB Infection","Prospective Validation of a Risk Prediction Model for MDRGNB Infection: A Multicenter Real-World Prospective Study","PRIOR","Inclusion Criteria:\n\n* Age ≥18 years;\n* ICU stay ≥48 hours;\n* At least one clinical microbiological specimen collected and submitted for testing within 48 hours of ICU admission, with the first submission time designated as the index time;\n* Core predictive variables of the model extractable from electronic medical records or laboratory information systems.\n\nExclusion Criteria:\n\n* For patients with multiple ICU admissions, only the first ICU stay was retained;\n* Missing or indeterminate primary outcome;\n* Missing key predictive variables that could not be handled according to prespecified rules.",{"count":173,"type":22},1000,"This prospective multicenter validation study aimed to evaluate the predictive performance of a previously developed model for MDRGNB infection in ICU patients.",[27],[177,178,179,27],"Prediction model","MDRGNB","ICU","2026-05-22",{"date":182,"type":39},"2026-05-27",{"date":180,"type":39},{"date":185,"type":22},"2028-12-31",{"name":187,"class":46},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School",11,{"id":190,"slug":191,"hasResults":12,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":82,"phases":199,"briefSummary":200,"conditions":201,"keywords":205,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":211,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":218},"100579855","ttv-based-management-of-long-term-immunosuppression-in-kidney-transplantation-100579855","NCT06829719","TTV-based mAnagement Of Long-term ImmunosuppreSsion in Kidney Transplantation","Personalization of Maintenance Immunosuppression Based on TTV Viral Load to Prevent Long-term Complications in Renal Transplantation","TAOIST","Inclusion Criteria:\n\n* Adult ≥ 18 years-old\n* Recipient of a kidney allograft (third graft at most)\n* 12 to 48 months post-transplantation\n* Stable graft function (defined as: delta creatininemia over the previous 6 months \\\u003C 20% and proteinuria \\\u003C 30mg\u002Fmmol)\n* On maintenance immunosuppression, which includes CNI (cyclosporin or tacrolimus) and MMF (Cellcept or Myfortic) with or without corticosteroids\n* Detectable TTV DNAemia at enrollment\n* No circulating DSA in solid phase assay\n* Undetectable BKV DNAemia at enrollment\n* Written informed consent\n\nExclusion Criteria:\n\n* Recipient of an HLA identical graft\n* Mutiple organ transplantation or functional transplant other than kidney\n* Maintenance immunosuppression that includes a mTOR inhibitor, belatacept or imurel\n* Presence of histological sign of active rejection (i+t \\> 2 and g+cpt \\> 2) on graft biopsy performed within 3 months before enrollment\n* Uncontrolled infection at inclusion\n* Infection requiring hospitalization within 3 months before inclusion\n* Diagnosis of a cancer of interest between the (current) transplantation and inclusion\n* Pregnant, unwillingness to practice adequate contraception or patient with a pregnancy plan during 3 years of study\n* Person not affiliated to a social security scheme or beneficiary of a similar scheme\n* Person subject to a legal protection measure (guardianship, curatorship) or deprived of liberty",{"count":198,"type":22},600,[142],"Long-term outcomes in kidney transplantation remain a significant challenge, as complications such as donor-specific antibodies (DSA), antibody-mediated rejection, infections, and cancer increasingly threaten graft and patient survival over time. The development of non-invasive biomarkers to guide the management of therapeutic immunosuppression beyond the first year post-transplantation is therefore a crucial unmet need.\n\nTorque Teno Virus (TTV), a non-pathogenic virus with a high prevalence worldwide, has emerged as a promising biomarker in this context. Its replication inversely reflects immune control by T cells, correlating with the depth of therapeutic immunosuppression. Additionally, its slow replication kinetics make TTV DNAemia a useful marker for evaluating patient adherence to immunosuppressive treatments.\n\nThe TAOIST study tests whether longitudinal monitoring of TTV DNAemia every six months, starting from the second year after transplantation, can guide the personalization of immunosuppressive therapy. The primary endpoint is the time to the first occurrence of complications linked to inadequate immunosuppression, including dnDSA, biopsy-proven rejection, infection, cancer, or graft loss. Secondary objectives include evaluating the acceptability of TTV DNAemia among healthcare professionals and assessing its cost-effectiveness compared to standard care. An ancillary objective examines the link between TTV DNAemia and the immunosuppressant possession ratio (IPR) to explore its potential as a marker of treatment adherence.",[27,202,203,204],"Cancer","Rejection","Kidney Transplantation",[206,207,208,209,210],"TTV","Biomarker","immunosuppression","precision medicine","kidney transplantation",{"date":182,"type":39},{"date":213,"type":39},"2025-04-23",{"date":215,"type":22},"2031-02-02",{"name":217,"class":46},"Hospices Civils de Lyon",4,{"id":220,"slug":221,"hasResults":12,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":12,"sex":18,"minAge":227,"maxAge":228,"enrollmentInfo":229,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":231,"conditions":232,"keywords":239,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":71},"100601389","the-peripheral-muscle-oxygenation-and-perfusion-score-as-a-new-non-invasive-tool-to-predict-elevations-in-c-reactive-protein-levels-in-neonates-100601389","NCT07109856","The Peripheral(-Muscle) Oxygenation and Perfusion Score as a New Non-invasive Tool to Predict Elevations in C-reactive Protein Levels in Neonates","The Peripheral(-Muscle) Oxygenation and Perfusion Score (POPScore) a New Non-invasive Tool to Predict Elevations in C-reactive Protein Levels in Neonates - a Prospective Phase II Observational Study","POP-Score","Inclusion Criteria:\n\n* birth weight ≥ 2000 grams\n* Signs of respiratory distress at time-point of inclusion (tachypnoea \\>60\u002Fmin, grunting, intercostal\u002Fsubcostal\u002Fjugular retractions, nasal flaring, supplemental oxygen or respiratory support)\n* Decision to conduct full life support\n* Written informed consent obtained within the first 6 hours after birth, before inclusion in the study\n* Age \\\u003C 6 hours\n\nExclusion Criteria:\n\n* No decision to conduct full life support\n* No written informed consent\n* Birth weight \\\u003C 2000 grams\n* Age \\> 6 hours\n* Severe congenital malformations,\n* Umbilical cord artery pH \\\u003C7.20","0 Hours","6 Hours",{"count":230,"type":22},93,"This is a prospective, single-center Phase II observational study investigating the predictive value of the \"Peripheral(-muscle) Oxygenation and Perfusion Score\" (POP-Score), a novel non-invasive composite index, for early detection of infection\u002Finflammation in neonates. The POP-Score combines peripheral muscle oxygenation measured via near-infrared spectroscopy (NIRS) with routinely monitored clinical parameters (heart rate, oxygen saturation, systolic blood pressure, and subcutaneous fat thickness). The study aims to determine the optimal cut-off value of the POP-Score measured within the first 6 hours after birth to predict elevated C-reactive protein (CRP ≥20 mg\u002FL) within 48 hours. Additionally, multi-site NIRS measurements (cerebral, peripheral muscle, intestinal, and flank) will be evaluated to assess their association with inflammation. The study includes term and moderate-to-late preterm neonates (birth weight ≥2000g) with respiratory distress, admitted to the neonatal intensive care unit at the Medical University of Graz.",[233,234,235,236,237,27,238],"Prematurity, Infections","NIRS","Near Infrared Spectroscopy","Preterm Neonates","Term Infant","Neonatal Sepsis, Early-Onset",[234,240,225,241,242],"near-infrared spectroscopy","neonates","preterm neonates","2026-05-12",{"date":245,"type":39},"2026-05-14",{"date":247,"type":39},"2025-11-27",{"date":249,"type":22},"2028-05-01",{"name":251,"class":46},"Medical University of Graz",{"id":253,"slug":254,"hasResults":12,"nctId":255,"briefTitle":256,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":258,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":261,"conditions":262,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":71},"100230861","validation-of-drug-assays-in-various-biological-matrices-100230861","NCT02283112","Validation of Drug Assays in Various Biological Matrices","Inclusion Criteria:\n\n* \\> 18 years of age\n\nExclusion Criteria:\n\n* Unable to give informed consent",true,{"count":260,"type":22},100,"This study aims to ensure that assays that measure drug concentrations are accurate and precise in different matrices when quantified using high performance liquid chromatography -tandem mass spectrometry (HPLC-MS\u002FMS). The study involves collecting samples of various bodily fluids to quantify antimicrobials, antivirals, oral contraceptives and erectile dysfunction agents. Samples will also be obtained from individuals not receiving these medications for quality control purposes.",[27],"2026-05-06",{"date":265,"type":39},"2026-05-11",{"date":267,"type":39},"2014-10",{"date":269,"type":22},"2027-12-31",{"name":271,"class":46},"University of Liverpool",{"id":273,"slug":274,"hasResults":12,"nctId":275,"briefTitle":276,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":278,"enrollmentInfo":279,"targetDuration":4,"studyType":82,"phases":281,"briefSummary":282,"conditions":283,"keywords":284,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":71},"100637420","phase-3-continuous-antibiotic-infusion-in-children-100637420","NCT07575009","Continuous Antibiotic Infusion In Children","Inclusion Criteria:\n\n* iv-antibiotic treatment is necessary\n* clinically stable\n* no need to stay in hospital\n* pump or cassette can be changed at the hospital or at home\n* care givers are able to contact hospital if needed\n* clinical diagnose is not uncertain\n* no allergy for the used antibiotic\n* the continuous antibiotic infusion hasn't been started yet or it has been initiated no more than 24 hours prior to study enrolment\n\nExclusion Criteria:\n\n* the pump cannot be carried with the child\n* the child must stay at the hospital for monitoring or other reason\n* unclear diagnose","16 Years",{"count":280,"type":22},150,[110],"Continuous intravenous antibiotic infusion using elastomeric pumps is well established in adult care and has been shown to be effective, safe, and cost-efficient, particularly for beta-lactams and vancomycin. In pediatric outpatient parenteral antimicrobial therapy (p-OPAT), home intravenous treatment is feasible and safe, improves quality of life, and reduces hospital stays and healthcare-associated infections. Elastomeric pumps offer practical advantages, including portability, ease of use, fixed infusion rates, and reduced drug handling, although they are limited by fixed flow rates and drug stability.\n\nThis prospective study at Tampere University Hospital (Tays) will evaluate the safety and cost-effectiveness of 24-hour continuous antibiotic infusions in children between January 2026 and January 2029. Eligible pediatric patients requiring intravenous antimicrobial treatment and suitable for home care will be included. Indications include serious bacterial infections such as bacteremia, osteomyelitis, septic arthritis, neutropenic fever, cystic fibrosis-related infections, and foreign body infections. The study antibiotics are benzylpenicillin, cloxacillin, piperacillin\u002Ftazobactam, and vancomycin, administered via CE-approved infusion devices for home use.\n\nChildren will receive continuous infusion either initially in hospital or directly from the emergency department if appropriate, with treatment duration and dosing comparable to standard intermittent regimens. Outcomes include safety, feasibility, cost-effectiveness, and patient-reported quality of life measured using PedsQL™. The study aims to determine whether continuous infusion can optimize pediatric antimicrobial care and healthcare resource utilization. Results will be published in peer-reviewed international journals.",[27],[285,286,287,288,289],"Continuous antibiotic infusion","Children","sepsis","osteomyelitis","Elastomeric pump","2026-05-04",{"date":292,"type":39},"2026-05-08",{"date":294,"type":39},"2026-04-21",{"date":296,"type":22},"2031-12-31",{"name":298,"class":46},"Tampere University Hospital",{"id":300,"slug":301,"hasResults":12,"nctId":302,"briefTitle":303,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":82,"phases":308,"briefSummary":309,"conditions":310,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":319,"locationsCount":71},"100586868","stop-sepsis-through-home-monitoring-cooperative-100586868","NCT06920979","Stop Sepsis Through Home Monitoring Cooperative","Stethoscoop","Inclusion Criteria:\n\n* This study will include patients aged 18 years or older, capable of giving informed consent, presenting with signs of severe acute infection with a risk of developing sepsis at the emergency department or at their primary care physician.\n\nExclusion Criteria:\n\n* Patients that are severely ill and require immediate hospitalization Qucik Sepsis Related Organ Failure score (QSOFA) ≥ 1 National Early Warning Score (NEWS) ≥ 5\n* Patients that demonstrate confusion, changes in mental state and\u002For an Mini-Mental State Examination (MMSE) below 26\n* Presence of neuropenic fever\n* Patients currently undergoing immunosuppressive therapy or chemotherapy\n* Patients with human immunodeficiency virus (HIV) or Acquired Immune Deficiency Syndrome (AIDS)\n* Suspicion of appendicitis, suspicion of meningitis or meningeal irritation, suspicion of or high risk of developing endocarditis\n* Complicated operation wounds at the time of screening\n* Proven pneumonia (CURB 65 score ≥ 1)\n* Emphysema, Chronic Obstructive Pulmonary Disease (COPD) GOLD \\>1 or interstitial lung disease\n* Patients with oxygen at home \\> 2 l\u002Fmin on a chronic basis (severe underlying lung disease?)\n* Severe cardiovascular disease including:\n\n  * Severe heart failure New York Heart Association (NYHA) class \\> 1\n  * Endoprosthesis\n  * Cardiac arrhythmia including atrial fibrillation\n  * Severe heart valve abnormalities\n  * Mechanic valve replacement\n  * Recent acute myocardial infarct or coronarography (less than 1y ago)\n  * Severe peripheral vascular morbidity\n* Acute chest pain (suspicion of acute coronary pathology)\n* Suspicion of\u002Fchance of septic arthritis",{"count":307,"type":22},120,[142],"In this study, patients presenting with acute infections at risk of developing sepsis will be followed in their home setting using wearables that provide (semi-)continue monitoring of vital signs as well as through follow up using a designated smartphone application. This is an innovative pilot study that will examine the potential of transmural care through telemonitoring for the first time in patients at risk for developing sepsis. By allowing for active follow-up of vital parameters in a transmural setting, this project aims to reduce the number of hospitalizations as compared to current practice. Furthermore, we aim to the number of patients referred to the emergency department after a visit at their primary care physician. Thereby, we aim to reduce the healthcare burden, yet providing the ability for rapid intervention in case of detarioration of patients, thereby reducing morbidity and mortality as well as associated costs.",[26,311,27,312],"Home Monitoring Follow-up","Innovativeness","2026-04-27",{"date":315,"type":39},"2026-05-01",{"date":317,"type":39},"2025-02-01",{"date":185,"type":22},{"name":320,"class":46},"University Hospital, Antwerp",{"id":322,"slug":323,"hasResults":12,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":327,"eligibilityCriteria":328,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":329,"targetDuration":4,"studyType":82,"phases":331,"briefSummary":333,"conditions":334,"keywords":336,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":351,"locationsCount":71},"100635701","phase-4-the-vancomycin-piperacillintazobactam-vpt-patient-safety-trial-vps-100635701","NCT07556107","The Vancomycin Piperacillin\u002FTazobactam (VPT) Patient Safety Trial (VPS)","A Randomized Controlled Trial Comparing Renal Effects of Vancomycin Combined With Either Piperacillin\u002FTazobactam or Meropenem: VPT Patient Safety (VPS) Study","VPS","Inclusion criteria\n\n1. Hospitalized or being hospitalized.\n2. Age \\>\u002F=18 yr old.\n3. Serious or suspected serious infection for which VPT or VM considered a broad-spectrum combination antibiotic backbone standard of care by clinician.\n4. Enrollment can be completed before the first dose of abx (ideally) and no later than before the second dose (alternatively).\n5. Consenting\u002Fenrollment will not clinically significantly delay abx administration.\n6. Baseline and \\>\u002F=1 prior Scr available (within 1 yr).\n7. Pt or LAR able to provide IC. Exclusion criteria\n\n1\\. AKI (\\>\u002F=moderate) (KDIGO stage 2-3) (Scr increase \\>\u002F=2-fold from chronic BL) (Scr based).\n\n2\\. CKD (\\>\u002F=moderately to severely decreased eGFR) (KDIGO stage G3b-G5) (by history or eGFR \\\u003C\u002F=44 mL\u002Fmin\u002F1.73M2) (Scr based).\n\n3\\. Beta lactam allergy. 4. Contraindication to VPT or VM. 5. Infection requiring VPT or VM specifically or another abx regimen. 6. Participation in another research study with interventions that may impact study endpoints.",{"count":330,"type":22},852,[332],"PHASE4","The VPT Safety Trial (VPS) compares two common antibiotic combinations to see how they affect the kidneys of patients in the hospital with serious infections. Both combinations are approved by the Food and Drug Administration (FDA). The goal is to help doctors know which combination is safer so they can make better choices for their patients.",[27,335,26],"Acute Kidney Injury",[337,338,339,340,341,342,343,344],"infection","hospitalized","AKI","cystatin c","vancomycin","piperacillin\u002Ftazobactam","meropenem","RCT","2026-04-22",{"date":347,"type":39},"2026-04-29",{"date":349,"type":22},"2026-06-01",{"date":185,"type":22},{"name":352,"class":46},"Bassett Healthcare",{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":258,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":362,"conditions":363,"keywords":364,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":163},"100250950","biomarkers-in-infection-100250950","NCT02545478","Biomarkers in Infection","Early Detection of Inflammatory Biomarkers in Infection","Inclusion Criteria for Infected subjects:\n\n* Age 18 years of age or older\n* Confirmed or suspected infection\n\nInclusion Criteria for Control Subjects:\n\n* Age 18 years of age or older\n* A non-infectious clinical presentation to include\n* Normal white blood cell count ( \\> 4,000 and\u002For \\\u003C 12,000)\n* Normothermia ( \\> 96.5 and\u002For less 100.4)\n* Absence of the following clinical complaints: productive cough, fever, pyuria, rash\n* No evidence of acute coronary syndrome\n\nExclusion Criteria for Control Subjects:\n\n\\- Suspected infection",{"count":361,"type":22},4200,"The purpose of this investigation is to evaluate how early biomarkers of infection and inflammation perform in identifying patients at risk for poor outcome in sepsis and septic shock.",[26,27,59],[365,337,366,367,368],"septic shock","inflammation","pathologic process","biomarkers","2026-04-13",{"date":371,"type":39},"2026-04-15",{"date":373,"type":4},"2006-04",{"date":375,"type":22},"2031-12",{"name":377,"class":46},"Beth Israel Deaconess Medical Center",{"id":379,"slug":380,"hasResults":12,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":12,"sex":18,"minAge":385,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":388,"conditions":389,"keywords":398,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":71},"100634157","potential-of-interface-care-models-to-deliver-more-appropriate-care-to-patients-with-acute-medical-illness-100634157","NCT07536035","Potential of Interface Care Models to Deliver More Appropriate Care to Patients With Acute Medical Illness","Potential of Interface Care Models to Deliver More Appropriate Care to Patients With Acute Medical Illness in Singapore and Decrease Utilisation of Acute Care Bed-days","Inclusion Criteria:\n\n* AMU inclusion criteria - admission from ED to AMU directly\n* Control group inclusion criteria - admission from ED to GW directly\n* Acute medical illnesses that includes infection-related conditions, falls-disequilibrium, and acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD).\n\nExclusion Criteria:\n\n* Below 21 years old\n* Patients undergoing active chemotherapy\n* Patients with active pregnancy\n* Patients admitted less than 24 hours\n* Cerebrovascular disease requiring thrombolysis or intravascular intervention","21 Years",{"count":387,"type":22},220,"Every country in the world is experiencing growth in both the size and the proportion of older persons. As a result of the changes, the profile and needs of people with medical illnesses have evolved. How care is delivered to patients has to keep pace with these changes, or patients will experience poor care at high cost and not have their needs met. A new model of care has emerged to meet these challenges: Acute Medical Unit. Despite considerable investment and popularity of this model, questions remain: (i) Who benefits most from this care model? (ii) How may these models be most effectively implemented for the best results? (iii) How effective are these models? Singapore is well-placed to answer these questions with its national healthcare system and excellent research institutions. The investigators plan to study how effective the model is by comparing patients with similar profiles exposed to both these care models compared to how hospital care is usually provided, looking for four differences: (i) how long patients stay in hospital, (ii) how often they use the emergency department (iii) quality of health (iv) cost. Additionally, the investigators seek to characterise patterns of health needs for this group of patients.",[390,391,392,393,27,394,395,396,397],"Falls Injury","Falls","Hospitalization in Acute Care","Chronic Obstructive Pulmonary Disease (COPD)","Acute Exacerbation of Asthma","Pneumonia","UTI - Urinary Tract Infection","URTI - Viral Upper Respiratory Tract Infection",[399,400,401,402,403,404,405],"Acute Medical Unit","Acute Medicine","Interface Care","Clinical effectiveness","Cost effectiveness","prospective observational","matched controlled","2026-04-10",{"date":408,"type":39},"2026-04-17",{"date":410,"type":39},"2024-09-30",{"date":412,"type":22},"2026-05-31",{"name":414,"class":46},"National University Hospital, Singapore",{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":421,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":18,"minAge":227,"maxAge":423,"enrollmentInfo":424,"targetDuration":4,"studyType":82,"phases":426,"briefSummary":427,"conditions":428,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":163},"100630204","phase-4-a-study-to-compare-the-efficacy-and-safety-of-extended-and-intermittent-infusion-of-beta-lactams-in-critically-ill-paediatric-patients-100630204","NCT07484633","A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients","A Protocol of a Randomised, Two-arm Superiority Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients","PEBBLE","Inclusion Criteria:\n\n* paediatric patients (0-17 years of age) with suspected or confirmed bacterial infection who are treated in a PICU or NICU and diagnosed with sepsis with a total Phoenix Sepsis Score ≥2 points, and the infection is clinically probable or confirmed by microbiological culture (e.g. from a blood culture, cerebrospinal fluid, urine, trachea, wound, etc.), excluding contamination;\n* who are receiving β-lactams including meropenem, piperacillin\u002Ftazobactam, cefepime and ceftriaxone;\n* who received the same β-lactam therapy within 24 hours prior to inclusion or started new β-lactam therapy due to clinical deterioration;\n* written consent of the parent or guardian is obtained.\n\nExclusion Criteria:\n\n* palliative care patients;\n* patients participating in other drug trials;\n* patients with impaired renal function if dosing modification is required (estimated Glomerular Filtration Rate \\[eGFR\\]\\\u003C50 mL\u002Fmin\u002F1.73m2 for meropenem, cefepime, and piperacillin\u002Ftazobactam; eGFR\\\u003C10 mL\u002Fmin\u002F1.73m2 for ceftriaxone);\n* patients undergoing plasmapheresis (TPE);\n* patients undergoing extracorporeal therapy (continuous kidney replacement therapy \\[CKRT\\] or extracorporeal membrane oxygenation \\[ECMO\\]);\n* β-lactam allergy;\n* patients admitted from another institution or department who have been on the same β-lactam treatment for more than 24 hours;\n* pregnancy.","17 Years",{"count":425,"type":22},110,[332],"The goal of this clinical trial is to examine the success and safety of administering certain antibiotics (beta-lactams) given in a longer 3-hour infusion to children (0-17 years) who are critically ill and have severe infection.\n\nThe main question it aims to answer is:\n\nIs the longer infusion more effective than the conventional short-term (0.5-hour-long) infusion? Researchers will compare the 3-hour-long infusion group to the 0.5-hour-long infusion group to determine whether the longer infusion can cure the infection earlier and whether it is equally safe. The doses are the same in the two groups. Only the duration differs until the patient receives the antibiotic.\n\nParticipants will:\n\n* be given the required antibiotic drug in a 3-hour-long or in a 0.5 hour-long infusion.\n* be examined to make sure their blood drug levels are correct. This will require two blood tests.\n* be treated according to routine care and have examinations and blood tests performed.",[27,26,429,430,431],"NICU","PICU","Beta Lactams","2026-04-07",{"date":369,"type":39},{"date":435,"type":22},"2026-04",{"date":437,"type":22},"2028-04",{"name":439,"class":46},"Semmelweis University",{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":4,"eligibilityCriteria":446,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":82,"phases":449,"briefSummary":450,"conditions":451,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":163},"100325992","home-hospital-for-suddenly-ill-adults-100325992","NCT03524222","Home Hospital for Suddenly Ill Adults","Home Hospital for Suddenly Ill Adults: A Clinical Trial","Inclusion Criteria:\n\n* Resides within either a 5-mile or 20 minute driving radius of emergency department\n* Has capacity to consent to study OR can assent to study and has proxy who can consent\n* \\>= 18 years-old\n* Can identify a potential caregiver who agrees to stay with patient for first 24 hours of admission. Caregiver must be competent to call care team if a problem is evident to her\u002Fhim. After 24 hours, this caregiver should be available for as-needed spot checks on the patient. This criterion may be waived for highly competent patients at the patient and clinician's discretion.\n* Primary or possible diagnosis of cellulitis, heart failure, complicated urinary tract infection, pneumonia, COPD\u002Fasthma, other infection, chronic kidney disease, malignant pain, diabetes and its complications, gout flare, hypertensive urgency, previously diagnosed atrial fibrillation with rapid ventricular response, anticoagulation needs, or a patient who desires only medical management that requires inpatient admission, as determined by the emergency room team.\n\nExclusion Criteria:\n\n* Undomiciled\n* No working heat (October-April), no working air conditioning if forecast \\> 80°F (June-September), or no running water\n* On methadone requiring daily pickup of medication\n* In police custody\n* Resides in facility that provides on-site medical care (e.g., skilled nursing facility)\n* Domestic violence screen positive\n* Acute delirium, as determined by the Confusion Assessment Method\n* Cannot establish peripheral access in emergency department (or access requires ultrasound guidance)\n* Secondary condition: end-stage renal disease, acute myocardial infarction, acute cerebral vascular accident, acute hemorrhage\n* Primary diagnosis requires multiple or routine administrations of intravenous narcotics for pain control\n* Cannot independently ambulate to bedside commode\n* As deemed by on-call medical doctor, patient likely to require any of the following procedures: computed tomography, magnetic resonance imaging, endoscopic procedure, blood transfusion, cardiac stress test, or surgery\n* High risk for clinical deterioration\n* Home hospital census is full (maximum 5 patients at any time)",{"count":448,"type":22},3000,[142],"The investigators propose a home hospital model of care that substitutes for treatment in an acute care hospital. Limited studies of the home hospital model have demonstrated that a sizeable proportion of acute care can be delivered in the home with equal quality and safety, reduced cost, and improved patient experience.",[27,452,453,454,455,456,457,458,459],"Heart Failure","COPD","Asthma","Gout Flare","Chronic Kidney Diseases","Hypertensive Urgency","Atrial Fibrillation Rapid","Anticoagulants; Increased","2026-03-16",{"date":462,"type":39},"2026-03-17",{"date":464,"type":39},"2018-01-18",{"date":466,"type":22},"2031-09",{"name":468,"class":46},"Brigham and Women's Hospital",{"id":470,"slug":471,"hasResults":12,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":4,"eligibilityCriteria":475,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":476,"targetDuration":4,"studyType":82,"phases":478,"briefSummary":479,"conditions":480,"keywords":484,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":71},"100629197","copper-supplementation-in-cirrhosis-100629197","NCT07471542","Copper Supplementation in Cirrhosis","A Pilot Randomized Controlled Trial to Determine the Biochemical Effect, Safety and Patient Reported Outcomes of Copper Supplementation in Patients With Cirrhosis","Inclusion Criteria:\n\n1. Adult patients age 18 or older with confirmed diagnosis of cirrhosis based on clinical history, exam, imaging, laboratory or histological criteria;\n2. Cirrhosis patients whose serum or plasma Cu are below the normal range (80-155 ug\u002FdL for women and 70-140 ug\u002FdL for men);\n3. Cirrhosis patients whose serum or plasma Cu are in the normal range but exhibit at least one clinical feature that has been associated with Cu deficiency. These include history of infections, unexplained anemia, severe leukopenia, iron overload, unexplained neurological symptoms such as ataxia or myelopathy, coagulopathy with spontaneous bleeding.\n\nPatients must meet inclusion criteria 1 AND 2, or 1 AND 3 in order to be considered for the trial\n\nExclusion Criteria:\n\n1. Patients with Wilson disease, cholestatic liver diseases including primary biliary cholangitis and primary sclerosing cholangitis, all of which are associated with Cu overload;\n2. Patients with fulminant hepatic failure;\n3. Renal failure with a creatinine clearance \\\u003C25 ml\u002Fminute;\n4. Hepatic encephalopathy more than grade 2 (Hepatic Encephalopathy in Chronic Liver Disease, 2014);\n5. MELD score \\>25 to minimize subject dropout due to been too ill;\n6. Serious non-liver related medical illnesses such as cardiopulmonary and renal diseases and non-liver malignancies;\n7. Active alcohol use;\n8. Pregnancy",{"count":477,"type":22},30,[142],"End stage liver disease or cirrhosis is a major cause of mortality in the United States and the world. Other than targeting the underlying cause, such as alcohol cessation and antiviral therapy, very few medical treatments can change the natural history of cirrhosis. Malnutrition is one of the few potentially modifiable factors that have been associated with cirrhosis severity and poor prognosis. The transition metal copper (Cu) is an essential trace metal that must be acquired from diet. Its metabolism is primarily regulated by the liver in its role as a master regulator of nutrients. In 2019, the investigators reported that Cu deficiency defined by below normal serum or liver concentrations occurred in a wide range of liver disorders and was associated with a severe disease phenotype. Improvement in liver function was observed in 2 of the 3 patients who received Cu supplementation. In 2023, the investigators conducted a longitudinal cohort study utilizing clinical, serum and liver explant tissue data from 183 cirrhosis patients. The investigators showed that Cu deficiency was associated with 2-fold higher infection rate and a more than 3-fold increase in the risk of death compared to patients with normal Cu status. These preliminary findings and the well-established importance of Cu in human health prompted the investigators to design the current pilot randomized, placebo-controlled, crossover trial to determine the effect of Cu supplementation on Cu dependent biochemical changes, patient safety and patient reported outcomes in cirrhosis.",[481,482,483,27],"Cirrhosis","Chronic Liver Disease","Fibrosis",[485,486,487],"copper","cirrhosis","malnutrition","2026-03-10",{"date":490,"type":39},"2026-03-13",{"date":492,"type":22},"2026-03-15",{"date":494,"type":22},"2028-12",{"name":496,"class":46},"University of Washington",{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":503,"eligibilityCriteria":504,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":19,"enrollmentInfo":505,"targetDuration":507,"studyType":23,"phases":4,"briefSummary":508,"conditions":509,"keywords":510,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":520,"locationsCount":523},"100623519","early-sepsis-recognition-tool-100623519","NCT07397689","Early Sepsis Recognition Tool","Sepsis Optimal Recognition Toolkit in Children (SORT): An Early Recognition Tool for Children in Asia","SORT","Inclusion Criteria:\n\n* Children \\\u003C 18 years old\n* Suspected infection defined by (1) blood culture performed (irrespective of result), AND (2) use of broad-spectrum anti-microbial agents, in the first 24 hours of admission\n\nExclusion Criteria:\n\n* 18 years and older\n* Patients who discharge At Own Risk (AOR) without outcome data",{"count":506,"type":22},40000,"30 Days","This study seeks to develop early recognition tools specially designed for children meeting the Phoenix definition and explore implementation science aspects by investigating facilitators and barriers to adopting Phoenix sepsis criteria in clinical practice. This addresses the critical need for systemic, evidence-based approaches to paediatric sepsis identification across diverse healthcare settings in Asia.",[27,26],[511,512,337,513],"Phoenix sepsis score","early recognition","child","2026-02-08",{"date":516,"type":39},"2026-02-11",{"date":518,"type":22},"2026-02",{"date":494,"type":22},{"name":521,"class":522},"KK Women's and Children's Hospital","OTHER_GOV",19,{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":528,"acronym":4,"eligibilityCriteria":529,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":530,"targetDuration":4,"studyType":82,"phases":532,"briefSummary":533,"conditions":534,"keywords":535,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":71},"100615033","bloom-pragmatic-feasibility-trial-100615033","NCT07287332","BLOOM: Pragmatic Feasibility Trial","Inclusion Criteria:\n\n* Adults ≥18 years of age\n* Admitted to one of the ICUs at the study center\n* Prescribed cefepime therapy by the care team\n\nExclusion Criteria:\n\n* Individuals will be those with a cephalosporin allergy\n* Received \\>1 dose of cefepime in the 24 hours before ICU admission\n* Transferred from an external hospital without compatible EHR\n* Does not have a cystatin C and a creatinine available for drug dosing\n* Acute kidney injury stage 2 or higher\n* Receiving renal replacement therapy\n* Treated with extracorporeal membrane oxygenation\n* Undergoing molecular adsorbent recirculating therapy at the time of beta-lactam initiation\n* Pregnant\n* Incarcerated\n* Declined Minnesota research authorization",{"count":531,"type":22},300,[142],"The goal of this study is to compare two different ways of dosing cefepime, an antibiotic for very sick patients - the usual approach to dosing or a new dosing method. The new dosing method uses only doses that are available in normal care, but choosing between the different doses is based on more information about the patient's body including their kidney function. The primary purpose of this study is to test how easy it is for healthcare professionals to use the new dosing method and how best to conduct the trial. The study will also assess if the new dosing method helps patients recover faster and reduces side effects.",[26,27],[536,26,537,538,539,540,541],"Beta-lactam antibiotics","Septic shock","Pharmacokinetics","Personalized medicine","Therapeutic drug monitoring","Infectious disease","2026-02-04",{"date":544,"type":39},"2026-02-06",{"date":546,"type":39},"2026-01-15",{"date":548,"type":22},"2027-07",{"name":550,"class":46},"Mayo Clinic",{"id":552,"slug":553,"hasResults":12,"nctId":554,"briefTitle":555,"officialTitle":556,"acronym":4,"eligibilityCriteria":557,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":558,"targetDuration":4,"studyType":82,"phases":560,"briefSummary":561,"conditions":562,"keywords":564,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":569,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":218},"100578085","reducing-blood-culture-contamination-with-the-use-of-a-needle-less-blood-draw-device-the-pivo-trial-100578085","NCT06806709","Reducing Blood Culture Contamination With the Use of a Needle-less Blood Draw Device (The PIVO Trial)","Reducing Blood Culture Contamination With the Use of a Needle-less Blood Draw Device (PIVO Pro): An Adaptive Group Sequential Randomized Controlled Trial (The PIVO Trial)","Inclusion Criteria:\n\n* Blood culture requested due to suspected bloodstream infection\n* Patients receiving a 22 gauge short peripheral intravenous catheter (or larger)\n\nExclusion Criteria:\n\n* Patients who have already commenced intravenous antimicrobial medications in the emergency department",{"count":559,"type":22},1148,[142],"Blood cultures (BCs) are a blood test to look for an infection. Two problems with the sample collection are contamination by germs outside of the blood and not collecting enough blood in the tube, resulting in unusable samples. Many patients requiring a BC also have a peripheral intravenous catheter (\"catheter\") but these are not normally used for blood sampling. This means that patients receive many painful needles for both catheter insertion and blood sampling. There is a needle-free blood collection device (PIVO Pro) which can be used with a catheter to collect a blood sample.\n\nThe goal of the PIVO Trial is to see if using the PIVO Pro for blood culture sample collection will have a lower amount of contamination than the usual method of blood sample collection. Patients 18 and older at 3 emergency departments will be included. Research nurses will look for patients in emergency who need a blood culture sample taken and they will be asked if they want to be involved in the trial. Half of the participants will use the PIVO Pro to take their blood sample and half will have the usual way of collecting blood.\n\nParticipants do not have to do anything specifically for the trial. Information about the blood collection and results of the blood culture will be collected from the medical records and recorded for the trial.",[563,27],"Blood Culture Contamination",[565,566,567],"PIVO Pro","Reducing blood culture contamination","Needle-less blood draw","2026-02-02",{"date":542,"type":39},{"date":571,"type":39},"2025-08-18",{"date":573,"type":22},"2026-12-31",{"name":575,"class":46},"The University of Queensland",{"id":577,"slug":578,"hasResults":12,"nctId":579,"briefTitle":580,"officialTitle":581,"acronym":582,"eligibilityCriteria":583,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":584,"targetDuration":4,"studyType":82,"phases":586,"briefSummary":587,"conditions":588,"keywords":593,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":603,"lastUpdatePostDateStruct":604,"startDateStruct":606,"completionDateStruct":608,"leadSponsor":609,"locationsCount":612},"100601449","microbial-cell-free-metagenomic-sequencing-for-suspected-infections-in-adult-immunocompromised-outpatients-100601449","NCT07110636","Microbial Cell-free Metagenomic Sequencing for Suspected Infections in Adult Immunocompromised Outpatients","A Prospective Randomized Basket Trial Evaluating the Clinical Utility of Plasma-based Microbial Cell-free Metagenomic Sequencing for Diagnosis and Management of Suspected Infections in Adult Immunocompromised Outpatients","OPTIMUM","Inclusion Criteria:\n\n* Basket Protocol\\* All participants must meet inclusion\n\n  1. Age ≥18\n  2. Included in one of the following immunocompromised groups: Solid organ transplant recipient (SOT) on chronic immunosuppression; Diagnosed with hematologic malignancy (HM) and\u002For recipient of a hematopoietic cell transplant (HCT); Diagnosed with a solid tumor and on specific types of active treatment; Recipient of drugs or novel biologics causing chronic immunosuppression; Diagnosed with an HIV infection; Diagnosed with inborn errors of immunity\n  3. Treating provider suspects infection and plans to obtain usual care diagnostic testing for the suspected infection (i.e., microbiologic testing)\n  4. Willing to provide research samples via blood draw\n  5. Willing and able to provide informed consent\n  6. Presenting for evaluation in the outpatient setting (includes telehealth)\n\n     \\*For Participants enrolled in Sub-Protocol A- Solid Organ Transplant\\*\n\n     All Sub-Protocol A subjects must meet the following:\n\n  \u003C!-- -->\n\n  1. Solid organ transplant recipient on transplant immunosuppression Non-lung recipients must meet one or more of the following characteristics: \\\u003C1 year from transplant; Augmented immunosuppression for suspected or confirmed rejection within the last 6 months; Confirmed systemic infection in last 6 months\n  2. Suspected infection defined by one or more of the syndromes: Cardiac; Lower Respiratory; Gastrointestinal \u002F Hepatobiliary; Genitourinary; Neurologic \u002F Ophthalmologic; Skin \u002F Soft tissue \u002F musculoskeletal; Not Otherwise Specified\n* For Participants enrolled in Sub-Protocol B- Hematological Malignancies and Transplant\\* All Sub-Protocol B subjects must meet the following:\n\n  1. Is included in at least one of the following groups: Hematologic malignancy (leukemia, myelodysplastic syndrome, lymphoma, multiple myeloma) and at least one of the following: Received chemotherapy or other systemic anti-cancer therapy associated with immunosuppressive effects within 90 days (e.g., monoclonal antibodies associated with B-cell or plasma cell depletion, bi-specific t-cell engagers, BTK inhibitors, BCL-2 inhibitors, PI3K inhibitors) within the last 90 days Note: Checkpoint inhibitors are not included unless given in combination with an immunosuppressive agent; Relapsed disease with chemotherapy anticipated in 60 days; ANC \\\u003C500 within the last 72 hours; Hypogammaglobulinemia IgG \\\u003C400 within the last 30 days; Allogeneic stem cell transplant for any clinical indication and at least one of the following: Within 1-year post-transplant; On systemic immunosuppressive therapy for GVHD treatment or prophylaxis; Autologous stem cell transplant for hematologic malignancy and at least one of the following: Within 6 months post-transplant; ANC \\\u003C500 within the last 72 hours; B cell and plasma cell targeted CAR-T therapy for hematologic malignancy and at least one of the following: Within 6 months of CAR-T cell infusion; CD4 T-cell \\\u003C200 within the last 30 days; IgG \\\u003C 400 within the last 30 days; ANC \\\u003C500 within the last 72 hours; On systemic immunosuppressive therapy for CRS\u002FICANS\n  2. Suspected infection defined by one or more of the syndromes: Cardiac; Lower Respiratory; Gastrointestinal \u002F Hepatobiliary; Genitourinary; Neurologic \u002F Ophthalmologic; Skin \u002F Soft tissue \u002F musculoskeletal; Not Otherwise Specified\n\nExclusion Criteria:\n\n* Basket Protocol\\* All participants must not meet the following:\n\n  1. Active symptoms are likely attributed to non-infectious causes.\n  2. Any other clinically significant medical condition that, in the opinion of the treating provider, makes participation undesirable, including but not limited to severe psychiatric illness, etc.\n\n     \\*For Participants enrolled in Sub-Protocol A- Solid Organ Transplant\\*\n\n     All Sub-Protocol A subjects must not meet the following:\n\n  \u003C!-- -->\n\n  1. Patients who have been previously evaluated (including via telehealth) for the same clinical signs and symptoms at this institution and pathogen-directed usual care (UC), diagnostic testing was ordered during that prior encounter, with one or more diagnostic test results still pending.\n  2. Patients with a suspected or confirmed primary upper respiratory infection (e.g., viral pharyngitis, sinusitis, or uncomplicated bronchitis) unless there is clinical suspicion of a concurrent lower respiratory or systemic infection requiring further diagnostic evaluation.\n* For Participants enrolled in Sub-Protocol B- Hematological Malignancies and Transplant\\* All Sub-Protocol B subjects must not meet the following:\n\n  1. Patients that have been previously evaluated (including via telehealth) for the same clinical signs and symptoms at this institution and pathogen-directed usual care (UC) diagnostic testing was ordered during that prior encounter with one or more diagnostic tests results still pending.\n  2. Patients with a suspected or confirmed primary upper respiratory infection (e.g., viral pharyngitis, sinusitis, or uncomplicated bronchitis) unless there is clinical suspicion of a concurrent lower respiratory or systemic infection requiring further diagnostic evaluation.",{"count":585,"type":22},2000,[142],"This clinical trial is designed to evaluate if adding the Karius Spectrum™ plasma test to usual care diagnostic tests, compared to usual care testing alone, among immunocompromised participants presenting with suspected infection in the outpatient setting leads to faster infection diagnosis and treatment. Participants will give a blood sample one time to be used for the testing. Information about the participant's illness and any treatments within 30 days following enrollment will be recorded.",[27,589,590,591,592],"Infections, Bacterial","Infections, Fungal","Infection Viral","Parasitic Disease",[594,595,596,597,598,599,600,601,602],"Karius","Karius Spectrum","Infection detection","metagenomic testing","Pathogen detection","Bacterial Infection","Fungal Infection","Parasitic Infection","Viral Infection","2026-01-28",{"date":605,"type":39},"2026-01-30",{"date":607,"type":39},"2025-10-27",{"date":185,"type":22},{"name":610,"class":611},"Karius, Inc.","INDUSTRY",6,{"id":614,"slug":615,"hasResults":12,"nctId":616,"briefTitle":617,"officialTitle":617,"acronym":4,"eligibilityCriteria":618,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":619,"enrollmentInfo":620,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":622,"conditions":623,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":624,"lastUpdatePostDateStruct":625,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":631,"locationsCount":71},"100621463","study-of-the-antibiotic-resistance-profile-of-enterobacterales-isolated-from-rectal-mucosal-buffer-of-prep-subjects-100621463","NCT07370948","Study of the Antibiotic-resistance Profile of Enterobacterales Isolated From Rectal Mucosal Buffer of PrEP Subjects","Inclusion Criteria:\n\n* age between 18 and 45 years\n* HIV-negative subjects undergoing an anorectal swab for Chlamydia trachomatis and Neisseria gonorrhoeae using NAAT as a normal diagnostic-assistance procedure provided for subjects using PrEP\n\nExclusion Criteria:\n\n* none","45 Years",{"count":621,"type":22},200,"The importance of the study lies mainly in expanding knowledge of the phenomenon of antibiotic resistance in subjects using PrEP, studying for the first time in this population the resistance phenotype in commensal Enterobacterales of the gastrointestinal tract.\n\nThe data obtained from this study could pave the way for potential surveillance and awareness programs for the critical and conscious use of antimicrobials in PrEP subjects in order to mitigate the problem of antibiotic resistance, which currently represents a real global challenge.",[27],"2026-01-22",{"date":626,"type":39},"2026-01-27",{"date":628,"type":39},"2025-05-30",{"date":630,"type":22},"2026-02-28",{"name":632,"class":46},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",{"id":634,"slug":635,"hasResults":12,"nctId":636,"briefTitle":637,"officialTitle":638,"acronym":639,"eligibilityCriteria":640,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":641,"targetDuration":4,"studyType":82,"phases":643,"briefSummary":644,"conditions":645,"keywords":646,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":650,"lastUpdatePostDateStruct":651,"startDateStruct":653,"completionDateStruct":655,"leadSponsor":657,"locationsCount":163},"100609212","kinetics-of-procalcitonin-to-reduce-unnecessary-antibiotic-use---comparing-procalcitonin-kinetics-guided-and-absolute-procalcitonin-value-guided-antibiotic-initiation-in-reducing-unnecessary-antibiotic-use-in-critically-ill-patients-100609212","NCT07211620","KInetics of Procalcitonin to Reduce Unnecessary aNtibiotic Use - Comparing Procalcitonin Kinetics-guided and Absolute Procalcitonin Value-guided Antibiotic Initiation in Reducing Unnecessary Antibiotic Use in Critically Ill Patients","KInetics of Procalcitonin to Reduce Unnecessary aNtibiotic Use (KIPRUN) - Protocol for a Multi-center, Randomized, Superiority Trial to Compare the Efficacy and Safety of Procalcitonin Kinetics-guided and Absolute Procalcitonin Value-guided Antibiotic Initiation in Reducing Unnecessary Antibiotic Therapy in Critically Ill Patients","KIPRUN","Inclusion Criteria:\n\n* Adult (18 years \\\u003C ) non-surgical, surgical, or trauma patients\n* Suspected new-onset infection on admission or during ICU stay\n* The source of infection is known or highly suspected, and source control has been implemented if needed (i.e., removal of an infected device (e.g., central line, endoprosthesis)\n* Two PCT values are available - one on the day of suspicion of infection and one 24±4 hours earlier.\n* Microbiology sampling has to be performed (according to all presumed sources - blood culture -aerobic and anaerobic, lower respiratory tract sample (tracheal aspirate\u002Fbronchoalveolar lavage), urine, etc.).\n* Written informed consent of the patient (or legal guardian if the patient cannot provide consent)\n\nExclusion Criteria:\n\n* Septic shock (hypotension requiring vasopressor therapy to maintain mean blood pressure of 65 mmHg or greater and having a serum lactate level greater than 2 mmol\u002FL after adequate fluid resuscitation)\n* Infections for which long-term antibiotic treatment is strongly recommended (e.g., infective endocarditis, osteoarticular infections, chronic prostatitis, tuberculosis)\n* Infections related to primary surgical intervention and adequate source control cannot be guaranteed (e.g., fecal peritonitis, pancreatic necrosectomy, infective necrotizing fascitis - i.e., Fournier's gangrene),\n* Indisputable infections (e.g., hepatic abscess, empyema)\n* Poor chance of survival (i.e., expected ICU stay less than 24 hours or initial Acute Physiology and Health Evaluation Score II (APACHE II) \\>30)\n* Admissions after cardiopulmonary resuscitation\n* Severe immunosuppression other than steroid use\n* stem-cell transplant recipients\n* solid organ transplant patients\n* HIV infection with a CD4 count of less than 200 cells\u002Fmm3\n* Neutropenia with less than 500 neutrophils\u002Fmm3\n* Patients on ABs within 72 hours before inclusion\n* Patients in pregnancy or breastfeeding. Women of childbearing age will be screened by a urine pregnancy test before inclusion in the study.",{"count":642,"type":22},250,[142],"The study aims to compare the efficacy and safety of an absolute procalcitonin (PCT) value-guided antibiotic initiation protocol and a protocol using the kinetics of PCT (the difference between the actual and the previous day value) in hemodynamically stable critically ill patients with suspected new-onset infection on admission or during ICU stay.\n\nThe main question it aims to answer:\n\n* Can the investigators decrease the number of unnecessary AB therapies using the kinetics of PCT insted of using absolute PCT values?\n* Is it safe to use PCT kinetics together with the clinical picture to guide AB initiation? AB therapy will be initiated according to predefined PCT protocols (Kinetics and Absolute Group). After 72 hours of treatment, an independent multidisciplinary team (infectologist, microbiologist and intensivist) will decide about the necessity of the treatment with all the relevant results in hand.",[27,26],[647,648,120,649],"procalcitonin","bacterial infection","kinetics","2026-01-08",{"date":652,"type":39},"2026-01-09",{"date":654,"type":39},"2025-11-06",{"date":656,"type":22},"2027-12",{"name":439,"class":46},{"id":659,"slug":660,"hasResults":12,"nctId":661,"briefTitle":662,"officialTitle":662,"acronym":663,"eligibilityCriteria":664,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":665,"targetDuration":4,"studyType":82,"phases":667,"briefSummary":668,"conditions":669,"keywords":673,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":675,"lastUpdatePostDateStruct":676,"startDateStruct":678,"completionDateStruct":680,"leadSponsor":682,"locationsCount":71},"100608613","diagnostic-and-prognostic-evaluation-of-vasorin-during-septic-shock-100608613","NCT07203833","Diagnostic and Prognostic Evaluation of Vasorin During Septic Shock","VASO-DIAG","Inclusion Criteria:\n\n* Adults over 18 years.\n* Patients admitted for less than 24 hours in intensive care unit of the CHU Amiens Picardie.\n* Group 1: patients with septic shock defined by sepsis with 2 mmol\u002Fl Lactates, requiring vasopressors to maintain mean blood pressure at 65 mmHg (despite adequate vascular filling) in the presence of fever (T°\\>38.3) with a documented or suspected infection\n* Group 2: patients with a shock defined by arterial hypotension requiring the use of vasopressors with 2 mmol\u002Fl Lactates but without suspected infection and apyrexie (T°\\\u003C38°). For example: vasoplegia post cardiac surgery with CBP or cardiogenic shock or hemorrhagic shock\n\nExclusion Criteria:\n\n* Pregnant women\n* Group 1 : No evidence of suspected or documented infection\n* Group 2 : Presence of fever and\u002For suspected infection",{"count":666,"type":22},144,[142],"Septic shock is the most severe form of infection. Currently, an early specific biomarker for septic shock is needed. Remember that shock situations are numerous, not only septic (eg hemorrhagic, cardiogenic...), and also accompanied by a severe pro-inflammatory state that it is sometimes difficult to distinguish from a septic state. Procalcitonin (PCT) is the most studied biomarker but still lacks sensitivity (77%) and specificity (79%). The investigators hypothesize that the Vasn could become this potential new biomarker and would allow a better diagnosis and thus the need or not to treat patients with antibiotics. The laboratory studies suggest a link between Vasn and septic shock. The goal of this project is to measure and compare plasma Vasn concentrations in 2 groups of patients = group 1: septic shock versus group 2: non-septic shock. Briefly, shock is defined as low blood pressure requiring vasopressor agents with confirmed infection (group 1) or without suspected infection such as patients admitted in intensive care unit post cardiac surgery with CBP (group 2). The investigators will also assess patient 28-day mortality to identify Vasn as a potential prognostic biomarker.",[670,671,672,207,27],"Vasorin","Septic Shock","Shock",[537,674,672,207,27],"vasorin","2026-01-06",{"date":677,"type":39},"2026-01-07",{"date":679,"type":39},"2025-10-19",{"date":681,"type":22},"2027-05",{"name":683,"class":46},"Centre Hospitalier Universitaire, Amiens",{"id":685,"slug":686,"hasResults":12,"nctId":687,"briefTitle":688,"officialTitle":688,"acronym":4,"eligibilityCriteria":689,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":690,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":692,"conditions":693,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":695,"lastUpdatePostDateStruct":696,"startDateStruct":698,"completionDateStruct":699,"leadSponsor":701,"locationsCount":163},"100616595","implementation-of-an-rt-pcr-assay-for-the-diagnosis-of-rickettsia-spp-infection-100616595","NCT07307651","Implementation of an RT-PCR Assay for the Diagnosis of Rickettsia Spp. Infection","Inclusion Criteria:\n\n* pazienti che presentano escara\n* pazienti con richiesta del dosaggio degli anticorpi anti-Rickettsia conorii\n\nExclusion Criteria:\n\n* None",{"count":691,"type":22},800,"Rickettsia2024 is a multicenter, tissue observational, retrospective and prospective cohort study. Enrollment will take place within the outpatient clinics of the Infectious Diseases and Dermatology Unit of the IRCCS AOUBO and, following an infectious disease consultation in the Bologna Metropolitan area, at the Hospitals and CAUs of the Bologna Local Health Authority. Within these UUOOs, biopsy samples from normal clinical practice are performed on patients with strong clinical suspicion of Rickettsia infection: therefore, it will not be necessary to perform any additional samples for the conduct of this study. Samples from the normal diagnostic process are sent to the Microbiology UOC, where they are subjected to various analyses. RT-PCR analyses (commercial or in-house kit) and assay of species-specific IgG antibodies will be performed according to clinical practice. Additional tests will be performed with a commercial kit for retrospective samples and with a home-made method for prospective samples.",[27,694],"Rickettsia Infections","2025-12-15",{"date":697,"type":39},"2025-12-29",{"date":677,"type":22},{"date":700,"type":22},"2029-06-07",{"name":632,"class":46}]