[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"infections-bacterial\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:infections-bacterial":23},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,40,63,103,138,170,202],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":24,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100629730","observational-study-of-raxibacumab-in-sporadic-cases-of-systemic-anthrax-100629730",false,"NCT07478471","Observational Study of Raxibacumab in Sporadic Cases of Systemic Anthrax","An Observational Clinical Study of Raxibacumab Use in Sporadic Cases of Systemic Anthrax","Inclusion Criteria:\n\n1. Any patient (women, including pregnant and lactating women, men, and children of all ages) with lab confirmed systemic anthrax in the US treated with a dose of raxibacumab from the Strategic National Stockpile (SNS).\n2. Patients willing and able to adhere to the procedures stated in the protocol.\n3. Patients (or legally acceptable representative of minors and unconscious adults) willing and able to give written informed consent\u002Fassent (as applicable) to participate in the study.\n\nNote: Systemic anthrax is defined in this protocol as a clinically compatible case of gastrointestinal, injectional, or inhalational anthrax; anthrax meningitis or bacteremia; or cutaneous anthrax with systemic effects (i.e., tachycardia, tachypnea, hypotension, hyperthermia, hypothermia, leukocytosis) or with lesions that involve the head, neck or upper torso, or are large, bullous, multiple, or surrounded by significant edema; plus confirmation by one of the following: Epidemiological link to a documented anthrax environmental exposure and\u002For laboratory test used for confirmation of systemic anthrax diagnosis by one of the following:\n\n* Isolation and culture of Bacillus spp. from an affected tissue or site;\n* Evidence of Bacillus spp. DNA by PCR in biological samples such as blood or cerebrospinal fluid (CSF) or lesion of affected tissue (skin, pulmonary, reticuloendothelial, or gastrointestinal);\n* Molecular Typing by Multiple-Locus Variable number tandem repeat Analysis (MLVA); Susceptibility to lysis by γ-phage;\n* QuickELISA™ Anthrax-PA Kit- Detection of anti-PA antibodies in serum, plasma, or pleural\u002Fascitic fluid or;\n* RedLine Alert™ Test- Qualitative identification of B. anthracis colonies\n\nExclusion Criteria:\n\n* There are no exclusion criteria for subjects enrolling in this study.","ALL",{"count":18,"type":19},10,"ESTIMATED","OBSERVATIONAL","This observational, open-label, single arm, study is designed such that it may be implemented for any individual with a lab confirmed sporadic case of systemic anthrax disease treated with raxibacumab outside of the current United States Prescribing Information (USPI). Systemic anthrax cases may include inhalational, gastrointestinal and injectional anthrax, anthrax meningitis or bacteremia or cutaneous anthrax with systemic effects.\n\nThis study is designed to evaluate the clinical effectiveness (including course of illness and survival), safety profile and pharmacokinetic (PK) analysis of raxibacumab from patients who are treated with raxibacumab as part of their clinical care following exposure to B. anthracis. Study data, PK sample provision\u002Fcollection and other investigational research will be collected prospectively to the extent possible at pre-specified time points. However, there is no reasonable way to identify prospectively the individuals likely to become eligible for participation in this study so most data in this study is anticipated to be collected retrospectively. Scavenged blood samples will be utilized where possible to maximize sample analyses and other investigational parameters. Therefore, both retrospective and prospective data collection are allowed in this protocol in order to maximize the amount of information obtained in subjects who have been administered raxibacumab. This field study will be the first opportunity to collect data on B. anthracis-exposed patients treated with raxibacumab, to better understand the clinical benefit and safety of the drug and to further inform patient care and treatment choices for management of anthrax.",[23],"Infections, Bacterial",[25,26,27],"Raxibacumab","anthrax","anti-toxin","NOT_YET_RECRUITING","2026-03-13",{"date":31,"type":32},"2026-03-17","ACTUAL",{"date":34,"type":19},"2027-05",{"date":36,"type":19},"2030-12",{"name":38,"class":39},"Emergent BioSolutions","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":4},"100222785","phase-4-clinical-benefit-and-safety-of-raxibacumab-in-patients-with-symptomatic-inhalational-anthrax-in-a-mass-exposure-scenario-100222785","NCT02177721","Clinical Benefit and Safety of Raxibacumab in Patients With Symptomatic Inhalational Anthrax in a Mass Exposure Scenario","A Field Study to Evaluate the Clinical Benefit and Safety of Raxibacumab in Patients With Symptomatic Inhalational Anthrax in a Mass Exposure Scenario","Inclusion Criteria:\n\n* Symptomatic inhalational anthrax linked to an identified mass exposure to B. anthracis.\n* Women, including pregnant and lactating women, men, and children of all ages who receive a dose of raxibacumab from the Strategic National Stockpile (SNS) as part of their clinical care for symptomatic inhalational anthrax will be eligible to enroll in this study.\n* Patients willing and able to adhere to the procedures stated in the protocol.\n* Patients (or legally acceptable representative of minors and unconscious adults) willing and able to give written informed consent\u002Fassent (as applicable) to participate in the study.\n\nExclusion Criteria:\n\n* There are no exclusion criteria for patients enrolling in this study.",{"count":48,"type":19},100,"INTERVENTIONAL",[51],"PHASE4","This field study is designed such that it may be implemented for any individual with symptomatic inhalational anthrax who has been administered raxibacumab for treatment of anthrax following a mass exposure scenario. This study is designed to describe the clinical effectiveness (including course of illness and survival) and safety profile from patients who are treated with raxibacumab as part of their clinical care following exposure to B. anthracis. Study data and other investigational research will be collected prospectively to the extent possible at pre-specified time points. However, because of the logistical complexities that would likely accompany a mass anthrax event, most data in this study is anticipated to be collected retrospectively. During such a mass anthrax event, scavenged blood samples will be utilized where possible to maximize sample analyses and other investigational parameters. Therefore, both retrospective and prospective data collection are allowed in this protocol in order to maximize the amount of information obtained in subjects who have been administered raxibacumab. This field study will be the first opportunity to collect data on B. anthracis-exposed patients treated with raxibacumab, to better understand the clinical benefit and safety of the drug and to further inform patient care and treatment choices for management of anthrax.",[23],[25,26,27],"2026-02-04",{"date":57,"type":32},"2026-02-06",{"date":59,"type":19},"2027-01",{"date":61,"type":19},"2035-12",{"name":38,"class":39},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":71,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":49,"phases":74,"briefSummary":76,"conditions":77,"keywords":82,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"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.","18 Years",{"count":73,"type":19},2000,[75],"NA","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.",[78,23,79,80,81],"Infection","Infections, Fungal","Infection Viral","Parasitic Disease",[83,84,85,86,87,88,89,90,91],"Karius","Karius Spectrum","Infection detection","metagenomic testing","Pathogen detection","Bacterial Infection","Fungal Infection","Parasitic Infection","Viral Infection","RECRUITING","2026-01-28",{"date":95,"type":32},"2026-01-30",{"date":97,"type":32},"2025-10-27",{"date":99,"type":19},"2028-12-31",{"name":101,"class":39},"Karius, Inc.",6,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":71,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":49,"phases":114,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":137},"100549918","phase-4-therapeutic-options-for-crab-100549918","NCT06440304","Therapeutic Options for CRAB","Therapeutic Strategies for Carbapenem-Resistant Acinetobacter Baumannii Infections: Study Protocol","TheraCRAB","Inclusion Criteria:\n\n* Surgical patients (abdominal, vascular, and polytraumatized patients)\n* Older than 18 years\n* Require postoperative treatment in the ICU\n* A positive sample (surveillance or diagnostic) for A. baumannii with signs of systemic infection\n\nInfection will be defined as a diagnostic microbiologically positive sample for A. baumannii and a surveillance microbiologically positive sample for A. baumannii with signs of systemic infection (elevated CRP, leukocytes, and body temperature).\n\nColonization will be defined as a positive surveillance microbiological sample for A. baumannii in the absence of signs of systemic infection (normal CRP, leukocytes, and body temperature).\n\nExclusion Criteria:\n\n* Allergy to the study medications\n* Positive surveillance swabs for A. baumannii without signs of systemic infection\n* Positive findings (surveillance or diagnostic) for carbapenem-sensitive A. baumannii\n* Refusal to participate in the research","90 Years",{"count":113,"type":19},108,[51],"CRAB infections in ICUs are on the rise, leading to higher morbidity, mortality, and healthcare costs due to resistance to most antibiotics, including carbapenems. The main resistance mechanisms include carbapenemases, efflux pumps, and changes in the bacterial cell wall.\n\nCurrent treatments include polymyxins (Colistin, Polymyxin B), which are effective but can lead to resistance, aminoglycosides (Amikacin, Gentamicin), which are limited by resistance, and tetracyclines (Tigecycline, Eravacycline), which are effective against CRAB. Fosfomycin is effective in combination treatments, and combination therapy (e.g., colistin with sulbactam, fosfomycin, or eravacycline) can enhance outcomes.\n\nPrevious research shows promise for combination therapies, improving treatment efficacy and reducing mortality. New regimens are being studied to find optimal combinations. Individualized dosing is crucial, considering patient-specific factors like age, weight, and renal function. Adjustments depend on the infection site and comorbidities.\n\nStrict infection control and antimicrobial stewardship programs (ASPs) are essential. ASPs focus on optimizing antibiotic use and reducing resistance through education and surveillance. Future directions include continued research for new drugs or combinations and strategies to overcome resistance and improve treatment efficacy.\n\nStudy goals include achieving negative samples after 10 days of therapy, 30-day survival, discharge rates, reduced SOFA scores, and improved clinical and radiological findings. A randomized study will compare colistin combined with fosfomycin, ampicillin\u002Fsulbactam, and eravacycline.\n\nIn summary, treating CRAB infections is complex, requiring combination therapy, individualized dosing, and strict infection control measures.",[23,117],"Sepsis Bacterial",[119,120,121,122,123,124,125,126],"Carbapenem-resistant Acinetobacter baumannii (CRAB)","Intensive Care Unit (ICU) infections","Polymyxins (colistin)","Combination antimicrobial therapy","Antimicrobial resistance mechanisms","Fosfomycin","Eravacyclin","Ampicillin\u002Fsulbactam","2026-01-16",{"date":129,"type":32},"2026-01-21",{"date":131,"type":32},"2025-01-30",{"date":133,"type":19},"2027-02",{"name":135,"class":136},"Clinical Hospital Centre Zagreb","OTHER",1,{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":16,"minAge":71,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":49,"phases":148,"briefSummary":149,"conditions":150,"keywords":154,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":169},"100596903","early-versus-late-stopping-of-antibiotics-in-adults-with-high-risk-hematological-malignanciesreceiving-cellular-therapies-and-fever-100596903","NCT07051525","Early Versus Late Stopping of Antibiotics in Adults With High-risk Hematological Malignancies\u002FReceiving Cellular Therapies and Fever","Early Versus Late Stopping of Antibiotics in Adults With High Risk Haematological Malignancies\u002FReceiving Cellular Therapies and Fever (ELSA- Adult)","ELSA-Adult","Inclusion Criteria:\n\nAdult patients ( ≥18 years) who are receiving either:\n\n* Conditioning chemotherapy for an autologous or allogeneic haematopoietic cell transplant or CAR T cell therapy, OR\n* Induction remission chemotherapy for acute leukaemia,\n\nAND develop fever ( ≥38degC) between time of initiation of chemotherapy\u002Fconditioning administration and ANC recovery to ≥500 cells\u002Fmm3 post the ANC nadir,\n\nAND fever subsequently has settled (\\\u003C38degC) for ≥48 and \\\u003C96h hours.\n\n\\[participants will be stratified into pre-neutropenic (ANC ≥500 cells\u002Fmm3) and neutropenic (ANC\\\u003C500 cells\u002Fmm3) strata based on ANC level at 48 hours post fever onset, as per international consensus definition of neutropenic fever\\]\n\nExclusion Criteria:\n\n* \\- Prolonged fever prior to defervescence (documented daily temperature ≥38.0°C for ≥ 5 days)\n* Documented positive blood culture for bacteria since onset of fever episode and prior to randomisation\n* Documented other infection (clinically or microbiologically defined) requiring antibacterial treatment\n* Grade 2 or higher mucositis (WHO) or neutropenic enterocolitis\n* Clinically unstable and\u002For admission to ICU at time of potential randomization\n* Within 28 days of last randomization\n* Prior randomization during current chemotherapy\u002Fconditioning cycle\n* Pregnant or breastfeeding\n* Currently being treated for CRS Grade 3 or 4, and\u002For ICANS Grade 3 or 4 (defined as per ASTCT Consensus Guidelines, Lee et al)",{"count":147,"type":19},214,[75],"Pre-neutropenic fever (PNF) (fever following chemotherapy but before developing low white cells) and neutropenic fever (NF) (fever in the setting of low white cells) are very common after chemotherapy for acute leukemia, bone marrow transplantation or Chimeric Antigen Receptor T-cell (CAR T) therapy. Often, there is no bacterial cause for fever found, and in the setting of a well patient with resolved fever, some studies have shown it to be safe to cease antibiotic therapy which was commenced at the onset of fever. This reduces the overall exposure to antibiotics, which can be beneficial to the patient (reduced risk of resistant bugs emerging, reduced serious side effects). However, some subgroups of high-risk patients have been underrepresented in these studies (in particular, those who have received a bone marrow transplant from a donor, those with longer duration of low white cells) and none have been performed in Australia, hence applying this data to our setting and patient groups is indirect and further data are needed. This study plans to recruit participants who have received chemotherapy for acute leukemia or a stem cell transplant (either their own cells or a donor's cells) or CAR T-cell therapy and perform a trial to compare early stopping of antibiotics (STOP arm) to the standard of care, which traditionally involves continuing antibiotics until the white cell count reaches above a specific threshold. The primary study outcome is duration of days free of antibiotics within 28 days of study allocation. The investigators will also observe for important clinical outcomes including rates of fever recurrence, bloodstream and other infections, intensive care admission and mortality. Patients will stay in hospital during this period, even in the setting of stopping antibiotics, and these antibiotics can be recommenced urgently according to the sepsis protocol if there is concern for infection.",[151,152,153,23],"Leukemia","CART Therapy","Transplantation, Stem Cell",[155,156,157,158,159],"EPIC","ELSA","Febrile neutropaenia","Febrile neutropenia","antibitoics","2025-12-07",{"date":162,"type":32},"2025-12-15",{"date":164,"type":32},"2025-12-03",{"date":166,"type":19},"2028-02-05",{"name":168,"class":136},"Peter MacCallum Cancer Centre, Australia",2,{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":16,"minAge":71,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":49,"phases":179,"briefSummary":181,"conditions":182,"keywords":192,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":137},"100550753","early-phase-1-novel-antisense-oligonucleotide-eye-drops-for-treating-antibiotic-resistant-bacterial-keratitis-100550753","NCT06451172","Novel Antisense Oligonucleotide Eye Drops for Treating Antibiotic-Resistant Bacterial Keratitis","ASOTARI","Inclusion Criteria:\n\n* The results of antimicrobial susceptibility testing in patients with bacterial keratitis showed multidrug-resistant bacterial infections, and the existing commercial antibiotics could not effectively control the disease.\n* Age over 18 years.\n* No systemic immune eye disease.\n* Good eyelid structure and blink function.\n* Exists the potential of visual recovery by evaluation of ocular structure and function.\n* Subjects or their legal guardians voluntarily participate in this study, sign informed consent, good compliance and cooperation with follow-up visits.\n\nExclusion Criteria:\n\n* Lacrimal coating and blink function loss.\n* Schirmer's test result is less than 2mm for severe dry eye disease.\n* Pregnant and lactating women (pregnancy defined in this study as positive urine pregnancy test).\n* Currently is involved in clinical trials of other drugs or medical devices.\n* Active eye infection (including but not limited to: blepharitis, infectious conjunctivitis, sclerotitis, endophthalmitis) in target eye or contralateral eye within 30 days prior to enrollment.\n* Ocular surface malignant tumor.\n* A history of allergic reaction or allergy to sodium luciferin, allergy to protein products used for treatment or diagnosis, allergy to ≥ 2 drugs or non-drug factors, or current allergic disease.\n* current in an infectious disease requiring oral, intramuscular or intravenous administration.\n* Patients with systemic immune diseases.\n* Any uncontrolled clinical problems (such as severe mental, neurological, cardiovascular, respiratory and other systemic diseases and malignant neoplasms).\n* Not effective contraception.\n* In uncontrolled hypertension, systolic is no less than 160 mmhg, diastolic is no less than 100 mmhg.\n* In uncontrolled diabetes, fasting glucose is no less than 10.0umol\u002FL.\n* Renal insufficiency, serum creatinine is more than 133umol\u002FL.\n* Arrhythmia, myocardial ischemia, myocardial infarction (diagnosed by electrocardiogram).\n* Liver dysfunction, al ANINE aminotransferase and aspartate aminotransferase levels are higher than 80 IU\u002FL.\n* Platelet level is below 100,000 \u002FuL or above 450,000 \u002FuL.\n* Hemoglobin level is below 10.0g\u002FdL (male) or 9.0g\u002FdL (female).\n* No anticoagulant was used, prothrombin time is higher than 16s, and thrombin time of activated part is higher than 50s.\n* HIV infection (HIV-positive).\n* Subjects lack compliance with the study or the ability to sign informed consent.\n* There are currently signs of systemic infection, including fever and ongoing antibiotic treatment (in this study, systemic infection was defined as deviation from normal values of white blood cells, lymphocytes, and neutrophils on routine blood tests).\n* Administration of Glucocorticoids and other systemic immunosuppressive drugs.\n* The investigator judges other conditions unsuitable for the trial",{"count":178,"type":19},20,[180],"EARLY_PHASE1","The purpose of this study is to evaluate the safety and efficacy of GP-asPNA for in vivo treatment of severe antibiotic resistant bacterial keratitis.",[183,184,23,185,186,187,188,189,190,191],"Bacterial Keratitis","Antibiotic-resistant Bacteria","Corneal Diseases","Eye Diseases","Vision Disorders","Sensation Disorders","Blindness","Antisense Peptide Nucleic Acid","Antibacterial Therapy",[183,23,185,186],"2024-06-08",{"date":195,"type":32},"2024-06-11",{"date":197,"type":32},"2023-10-11",{"date":199,"type":19},"2026-10-31",{"name":201,"class":136},"Eye & ENT Hospital of Fudan University",{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":16,"minAge":71,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":212,"conditions":213,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":137},"100548924","routinely-collected-clinical-data-and-evaluation-of-antimicrobial-target-attainment-100548924","NCT06427317","Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment","Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment and the Potential Role of Therapeutic Drug Monitoring in UK Infection Management","DATATDM","Inclusion Criteria:\n\n18 years of age or above.\n\n* Under follow-up for management of infection at Imperial College NHS Trust\n* Received a beta-lactam antibiotic within the last 48 hours (or are planned to start imminently).\n* Provides informed written consent see below, or lacks capacity to provide consent because of one of the following conditions (and declaration provided by personal consultee):\n* Delirium which may be caused or exacerbated by having an infection.\n* Suspected\u002Fconfirmed central nervous system infection.\n* Critical illness requiring sedation and\u002For intubation and ventilation which is caused by or exacerbated by having an infection.\n\nExclusion Criteria:\n\n* Less than 18 years of age\n\n  * Severe anaemia (Hb \\\u003C 70g\u002Fl)\n  * Platelets \\\u003C 50x10\\^9\u002Fl, INR \\>1.5 or other known blood clotting impairment\n  * Patient with terminal diagnosis receiving palliative care input who may experience distress if approached for this study.\n  * Enrolled in a clinical trial which stipulates exclusion from other studies including observational studies.\n  * Patients with restricted liberty, prisoners or under legal protection.",{"count":211,"type":19},323,"The primary aim of the study is to determine the proportion of individuals receiving beta-lactam antibiotics at Imperial College Healthcare NHS Trust in whom drug concentration targets are achieved.",[23,214,215,216],"Pharmacokinetics","Drug Monitoring","Drug-Related Side Effects and Adverse Reactions","2024-05-21",{"date":219,"type":32},"2024-05-23",{"date":221,"type":32},"2024-03-19",{"date":223,"type":19},"2027-03-19",{"name":225,"class":136},"Imperial College London"]