[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"severe-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:severe-infection":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,47,78,101,128,159,189,214,243,266,290],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100640045","infectious-complications-in-hematological-patients-under-treatment-with-bispecific-antibodies-100640045",false,"NCT07609576","Infectious Complications in Hematological Patients Under Treatment With Bispecific Antibodies.","Multicenter Study Proposal: Infectious Complications in Hematological Patients Under Treatment With Bispecific Antibodies.","Inclusion Criteria:\n\n1. Adult patients (≥18 years) diagnosed with hematologic malignancies (e.g., multiple myeloma, non-Hodgkin lymphoma) who are receiving treatment with bispecific antibodies.\n2. Patients must have initiated BsAb therapy within 30 days prior to study enrollment.\n3. Ability to provide informed consent.\n4. Severe infections will be recorded the first year, but infectious events past confirmed relapse or new treatments for the underlying disease will not be recorded.","ALL","18 Years",{"count":19,"type":20},350,"ESTIMATED","2 Months","OBSERVATIONAL","This is a prospective, multicenter, observational cohort study involving patients with hematologic malignancies who are receiving bispecific antibody therapy. The primary objective of this study is to evaluate the incidence, type, and severity of infectious complications in hematologic patients undergoing treatment with bispecific antibodies.\n\nSecondary objectives include identifying risk factors associated with infection, comparing infectious outcomes across different hematologic malignancies and BsAb types, and assessing the impact of infections on overall treatment outcomes.",[25,26,27,28,29,30],"Lymphoma Neoplasms","Myeloma Multiple","Severe Infection","CMV Reactivation","Biespecific Treatment","Biespecific",[32,33],"prophylaxis","infections management","RECRUITING","2026-05-21",{"date":37,"type":38},"2026-05-27","ACTUAL",{"date":40,"type":38},"2026-05-14",{"date":42,"type":20},"2026-06-30",{"name":44,"class":45},"Infanta Leonor University Hospital","OTHER",2,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100613936","phase-4-individualized-multiplex-pathophysiological-treatment-of-severe-acute-infections-n-acetylcysteine-100613936","NCT07273071","Individualized Multiplex Pathophysiological Treatment of Severe Acute Infections: N-Acetylcysteine","A Randomized, Placebo-controlled, Blinded, Parallel-group Clinical Trial to Assess the Efficacy of N-acetylcysteine in Adults With Acute Infections or Sepsis and Evidence of Liver Dysfunction: the IMPACT-NAC Trial","IMPACT-NAC","Inclusion criteria\n\n1. Age ≥18 years\n2. Documented clinical suspicion of infection\n3. Model for end-stage liver disease (MELD) score ≥9\n\nExclusion criteria\n\n1. Admitted to hospital \\>24 hours before randomization\n2. Any previous severe anaphylaxis\n3. Other known allergy to N-acetylcysteine\n4. Ongoing treatment with N-acetylcysteine at randomization\n5. Documented clinical suspicion of bile duct obstruction\n6. Refractory circulatory shock\n7. Informed consent not obtainable\n8. Inability to read and understand Danish to a degree that allows valid informed consent and completion of trial assessments\n9. Involuntary admission under the psychiatric law\n10. Expected initiation of palliative care within 48 hours of randomization\n11. Ongoing treatment with nitroglycerin\n12. Any other condition deemed by the investigator to compromise patient safety or trial integrity (e.g., severe coagulopathy, uncontrolled bleeding, diabetic ketoacidosis)",{"count":56,"type":20},360,"INTERVENTIONAL",[59],"PHASE4","The primary objective of the IMPACT-NAC trial is to assess the effects of N-acetylcysteine on survival and hospital length of stay in adults admitted to the emergency department with acute infection or sepsis and evidence of liver dysfunction.\n\nThe main question it aims to answer is: does N-acetylcysteine increase the number of days alive and out of the hospital within the first 14 days after enrolment in the trial?\n\nTo answer this question, we will conduct a randomized, double-blinded controlled trial of 360 participants.\n\nParticipants will be randomized to either N-acetylcysteine or placebo (normal saline without active drugs). This will be administered as an infusion during four hours within the first day of hospital admission.",[62,63,27],"Sepsis","Acute Infection",[62,63,27,65,66],"Acetylcysteine","Liver dysfunction","NOT_YET_RECRUITING","2026-03-23",{"date":70,"type":38},"2026-03-27",{"date":72,"type":20},"2026-07",{"date":74,"type":20},"2028-05",{"name":76,"class":45},"Theis S. Itenov",1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":77},"100536093","communautary-pediatric-bacterial-infection-in-intensive-care-unit-100536093","NCT06260345","CommunautAry Pediatric bacteRial Infection in Intensive CarE Unit","Observatory of Pediatric Severe Communautary Bacterial Infections","CAPRICE","Inclusion Criteria:\n\n* Age \\\u003C18 years (only hospitalized children)\n* Severe communautary bacterial infection defined by hospitalization in a pediatric intensive care unit (documentation of infection by identification of the bacteria in a sterile environment).\n\nExclusion Criteria:\n\n* Refusal by one of the parents or by Child in understanding age\n* Nosocomial infection",{"count":87,"type":20},3000,"Severe bacterial infections are a worldwide scourge. However, the epidemiology of this type of infection varies over time. It is therefore essential to monitor them in order to prevent them more effectively. At this time, in France, no monitoring exists for this kind of infections.",[90,27,91],"Hospitalized Children","Invasive Bacterial Infection","2026-03-17",{"date":94,"type":38},"2026-03-19",{"date":96,"type":38},"2024-01-01",{"date":98,"type":20},"2030-01-01",{"name":100,"class":45},"Association Clinique Thérapeutique Infantile du val de Marne",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":112,"studyType":22,"phases":4,"briefSummary":113,"conditions":114,"keywords":115,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":77},"100433415","chinese-picu-collaborative-network-on-pathogens-and-drug-resistance-of-severe-infections-100433415","NCT04923828","Chinese PICU Collaborative Network on Pathogens and Drug Resistance of Severe Infections","Children's Hospital of Fudan University","Inclusion Criteria:\n\n* PICU patients with severe infection\n\nExclusion Criteria:\n\n* Non-infected patient","1 Month","16 Years",{"count":111,"type":20},2000,"1 Year","To investigate PICUs in major cities in China by establishing a high-quality standardized clinical database of PICU inpatients Incidence, fatality rate, pathogen distribution, anti-infective treatment of community-acquired\u002Fnosocomial infections in inpatients.",[27],[116,117,118,119],"PICU","pathogen","severs infection","drug resistance","2026-02-12",{"date":122,"type":38},"2026-02-17",{"date":124,"type":38},"2023-12-31",{"date":126,"type":20},"2026-12-31",{"name":106,"class":45},{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":135,"enrollmentInfo":136,"targetDuration":138,"studyType":22,"phases":4,"briefSummary":139,"conditions":140,"keywords":143,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":4},"100620157","mechanisms-of-prognostic-regulation-andprecision-phenotype-ldentification-in-severe-infections-driven-by-specializedpro-resolving-mediators-100620157","NCT07353970","Mechanisms of Prognostic Regulation andPrecision Phenotype Ldentification in Severe Infections Driven by SpecializedPro-Resolving Mediators","MPR-PPI-SPMs","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Admission to the intensive care unit (ICU)\n* Diagnosis of severe infection or sepsis, as determined by the treating physician according to current clinical criteria\n* Ability to obtain blood samples as part of routine clinical care within 24-48 hours after ICU admission\n* Informed consent provided by the patient or legally authorized representative (when applicable)\n\nExclusion Criteria:\n\n* Known pregnancy\n* Known immunosuppressive disease (e.g., hematologic malignancy, advanced HIV infection)\n* Use of long-term immunosuppressive therapy or systemic corticosteroids prior to ICU admission\n* Pre-existing end-stage disease with expected survival \\\u003C 28 days (e.g., end-stage cancer receiving palliative care)\n* Enrollment in interventional clinical trials that may influence immune or inflammatory responses\n* Refusal of informed consent by the patient or legal representative\n* Patients in whom blood sampling or follow-up is not feasible (e.g., expected transfer, withdrawal of life-sustaining treatment within 24 hours)","100 Years",{"count":137,"type":20},300,"28 Days","This is a prospective observational study involving adult patients with severe infection who are admitted to the intensive care unit (ICU). Severe infection and sepsis are major causes of death worldwide. Many patients experience uncontrolled inflammation or immune suppression, but current tests are limited in identifying which patients are at highest risk.\n\nThis study focuses on specialized pro-resolving mediators (SPMs), a group of naturally occurring lipid molecules that help the body turn off inflammation and promote healing. Blood samples that are collected during routine clinical care will be used to measure levels of SPMs. No additional blood draws or experimental treatments will be performed.\n\nThe purpose of this study is to understand how SPM levels change over time in patients with severe infection and how these changes relate to organ function and outcomes such as survival. By combining SPM measurements with routine laboratory results, immune cell counts, and imaging findings, the study aims to identify different clinical phenotypes and to develop tools that may help doctors recognize high-risk patients earlier in the future.\n\nAll participants will receive standard medical care determined by their treating physicians. No experimental drugs or interventions are given as part of this study.",[62,27,141,142],"Multiple Organ Dysfunction Syndrome","Critical Illness",[144,145,146,147,148,149],"Specialized pro-resolving mediators","SPM","Resolvin D1","Immune resolution","Inflammation resolution","Critical care","2026-01-19",{"date":152,"type":38},"2026-01-21",{"date":154,"type":20},"2026-01-15",{"date":156,"type":20},"2028-01-16",{"name":158,"class":45},"Second Affiliated Hospital of Wenzhou Medical University",{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":167,"enrollmentInfo":168,"targetDuration":4,"studyType":57,"phases":170,"briefSummary":171,"conditions":172,"keywords":173,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":4},"100578471","phase-4-continuous-infusion-versus-intermittent-dosing-of-ceftazidimeavibactam-in-critically-ill-patients-100578471","NCT06811727","CONTinuous Infusion Versus Intermittent Dosing of ceftaZidime\u002FAVIbactam in Critically Ill Patients","CONTinuous Infusion Versus Intermittent Dosing of ceftaZidime\u002FAVIbactam in Critically Ill Patients With Klebsiella Pneumoniae OXA-48 or Pseudomonas Aeruginosa Infections: A Single-centre Randomized Open-label Trial (ZAVICONT)","ZAVICONT","Inclusion Criteria:\n\n1. General\n\n   1. Age above or equal to 18 years of age.\n   2. Able to provide informed consent personally or by his\u002Fher next of kin, as requested by the Ethics Committee.\n2. Disease-specific\n\n   1. Critically ill patients requiring admission to the intensive care unit (medical or surgical).\n   2. Diagnosed with severe infections.\n   3. At least one microbiological sample positive for Klebsiella pneumoniae OXA-48 or Pseudomonas aeruginosa.\n   4. Requiring a prescription for ceftazidime\u002Favibactam, by clinical judgement\n\nExclusion Criteria:\n\n1. General\n\n   1. Known or suspected hypersensitivity to ceftazidime\u002Favibactam, excipients, or any other cephalosporin antibacterial agent. Severe hypersensitivity (e.g. anaphylactic reaction, severe skin reaction) to any other β-lactam antibacterial agent (e.g. penicillins, monobactams or carbapenems).\n   2. Withdrawal of informed consent.\n   3. Age above 85 years of age.\n   4. Female who is pregnant or breast-feeding.\n   5. Participation (i.e. signed informed consent) in any other interventional clinical trial of an approved or non-approved antibacterial agent within 30 days before screening.\n   6. Any disorder which, in the investigator's opinion, might jeopardize the participant's safety or compliance with the protocol.\n2. Laboratory values\n\n   1\\. Severe neutropenia before or during ceftazidime\u002Favibactam administration.\n3. Medical conditions\n\n   1. Death within 48 hours following randomization.\n   2. Concomitant acquired immunodeficiency syndrome.\n   3. Presence or history of malignant neoplasms or in situ carcinomas.\n   4. Duration of ceftazidime\u002Favibactam administration is shorter than 72 hours.","85 Years",{"count":169,"type":20},140,[59],"Ceftazidime\u002Favibactam (CZA) is an essential treatment option for managing infections caused by multidrug-resistant (MDR) gram-negative (G-) bacteria, including Klebsiella pneumoniae OXA-48 and carbapenem-resistant Pseudomonas aeruginosa. Critically ill intensive care unit (ICU) patients frequently exhibit altered pharmacokinetics (PK) of CZA, potentially compromising optimal PK\u002Fpharmacodynamic (PD) target attainment with standard dosing regimens. This study compares the efficacy of continuous infusion (CI) versus conventional intermittent dosing (ID) of CZA in critically ill ICU patients with severe infections caused by K. pneumoniae OXA-48 or P. aeruginosa.\n\nThis single-centre, randomized, open-label trial will be conducted at a tertiary care hospital within the University Hospital Centre in Zagreb, Croatia, with a 1:1 allocation ratio. One hundred forty critically ill ICU patients requiring CZA treatment will be randomized to receive either ID (2 g\u002F0.5 g every 8 hours over 2 hours) or an equivalent dose in CI (6 g\u002F1.5 g continuously over 24 hours).\n\nThe primary outcome is the microbiological success rate. Secondary outcomes include clinical success rate, time to symptom improvement, length of ICU and hospital stay, 28-day all-cause mortality, pathogen recurrence rate, time to weaning from mechanical ventilation, cumulative vasoactive-inotropic score, adverse events, and the ratio of ceftazidime plasma concentration to the pathogen's minimum inhibitory concentration (C\u002FMIC).\n\nThis trial seeks to provide evidence on the optimal administration strategy for CZA in critically ill ICU patients with severe infections due to MDR G- pathogens.",[27],[174,175,176,177,178,179],"ceftazidime\u002Favibactam","continuous infusion","critically ill","ICU","Klebsiella pneumoniae OXA-48","Pseudomonas aeruginosa","2025-04-19",{"date":182,"type":38},"2025-04-22",{"date":184,"type":20},"2025-05-01",{"date":186,"type":20},"2027-08-01",{"name":188,"class":45},"Ivan Šitum, MD",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":16,"minAge":196,"maxAge":109,"enrollmentInfo":197,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":199,"conditions":200,"keywords":202,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":77},"100438563","systematic-screening-for-primary-immunodeficiencies-in-patients-admitted-for-severe-infection-in-pediatric-intensive-care-unit-100438563","NCT04990908","Systematic Screening for Primary Immunodeficiencies in Patients Admitted for Severe Infection in Pediatric Intensive Care Unit","SPYSI","Inclusion criteria:\n\n* Inclusion age less than 16 years\n* Inclusion age \\> 3 months of actual age for term infants and \\> 3 months for former preterm infants.\n* Documented severe infection (bacterial, viral, fungal) at the University Hospital Center of Montpellier, Toulouse or Marseille\n* Severe infections concerned by the study: any infection requiring hospitalization in pediatric intensive care (more than 24 hours) including:\n* meninges or brain lesions, pleuro-pneumopathy, any infection associated with sepsis and\u002For an opportunistic germ, septic shock, etc.\n* Encephalitis and encephalomyelitis of infectious origin\n* Child benefiting from a social security system\n* Collection of parental\u002Flegal representative consent\n\nExclusion criteria:\n\n* Undocumented severe infections\n* Acute bronchiolitis\n* Children admitted with isolated SRV bronchiolitis without further complications from the infection;\n* Previous comorbidity explaining the infection and\u002For stay in ICU\u002FContinuing Care: Primary or known secondary immune deficiency; burns; risk factors for non-infectious epilepsy (encephalopathy, known epilepsy, head trauma), pneumonia caused by swallowing disorders or tracheotomy or chronic lung disease, asthma, meningitis favored by cochlear implants, breach of blood-brain barrier or neuromeningetic material, deep infection on implanted material or within 48h after surgery, cardiovascular decompensation; any other chronic conditions that may contribute to infection;\n* Inability to obtain consent from parents\u002Flegal guardians.","3 Months",{"count":198,"type":20},100,"Severe infections in pediatric intensive care unit are not uncommon. Historically, the diagnosis of hereditary (primary) immune deficiency required a combination of recurrent clinical signs and biological stigmas. This paradigm is currently being questioned, and grows the hypothesis of a potential underlying genetic susceptibility in any severe infection. To date, the proportion of severe infections explained by an underlying immune deficiency is unknown.\n\nThe aim of this prospective study is to assess the incidence of primary immune deficiencies in children with severe infection, regardless of their etiology.",[27,201],"Severe Immune Deficiency",[203,204],"genetics","screening","2024-03-28",{"date":207,"type":38},"2024-03-29",{"date":209,"type":38},"2023-09-04",{"date":211,"type":20},"2026-09-04",{"name":213,"class":45},"University Hospital, Montpellier",{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":16,"minAge":222,"maxAge":223,"enrollmentInfo":224,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":225,"conditions":226,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":77},"100499869","invasive-group-a-streptococcal-infection-100499869","NCT05788861","Invasive Group A Streptococcal Infection","French Pediatric Nationwide Observatory of Invasive Group A Streptococcal Infection (in Childen for 0 to 18 Ages)","ISAI","Inclusion Criteria:\n\n* Age\\\u003C18 years\n* Documented invasive Group A Streptococcus infection (identification of GAS in a normally sterile site or from another site in case of toxin shock or necrotizing dermo-hypodermatitis)\n\nExclusion Criteria:\n\n* Opposition of the patient or his\u002Fher legal representative","1 Day","17 Years",{"count":198,"type":20},"This study is observational, retrospective and prospective study in pediatric patients hospitalized with invasive streptococcal A infection",[227,228,27,229,230,231,232,233,234],"Sepsis Due to Streptococcus, Group A","Risk Factors","Medical Care","Medical Complications","Outcome, Fatal","Therapy","Strain","Virulence Factors","2024-02-07",{"date":237,"type":38},"2024-02-08",{"date":239,"type":38},"2022-09-01",{"date":241,"type":20},"2026-09-01",{"name":100,"class":45},{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":252,"conditions":253,"keywords":254,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":77},"100530372","phageinlyon-clinic-cohort-study-a-descriptive-study-of-severe-infections-treated-with-phage-therapy-at-the-hcl-100530372","NCT06185920","PHAGEinLYON Clinic Cohort Study: a Descriptive Study of Severe Infections Treated With Phage Therapy at the HCL.","Non Interventional Retrospective and Prospective Single Center Descriptive Study of Severe Infections Treated With Phage Therapy at the Hospices Civils de Lyon (PHAGEinLYON Clinic Cohort Study).","Inclusion Criteria:\n\n* Patient with severe infection treated with bacteriophage in the Hospices Civils de Lyon from 01\u002F01\u002F2015 to 01\u002F01\u002F2033\n* PHAGEinLYON Clinic cohort study information notice provided to the patient\n\nExclusion Criteria:\n\n* Opposition of trial participant",{"count":251,"type":20},250,"PHAGEinLYON Clinic cohort study is a single site non-interventional retrospective and prospective study, initiated by the Hospices Civils de Lyon. Population targeted are patients with a severe infection treated with bacteriophage in the Hospices civils de Lyon from 2015 to 2033. The primary objective is to describe the severe infections treated with phagotherapy. 250 patients will be included in the study.",[27],[255,256],"bacteriophage","severe infection","2023-12-14",{"date":259,"type":38},"2023-12-29",{"date":261,"type":38},"2023-02-01",{"date":263,"type":20},"2034-02-01",{"name":265,"class":45},"Hospices Civils de Lyon",{"id":267,"slug":268,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":57,"phases":275,"briefSummary":276,"conditions":277,"keywords":278,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":77},"100528522","phase-4-clinical-study-of-individualized-vancomycin-dosing-based-on-population-pk-model-100528522","NCT06161870","Clinical Study of Individualized Vancomycin Dosing Based on Population PK Model","Clinical Study of Individualized Vancomycin Dosing Based on Population Pharmacokinetic Model for Severe Infections","Inclusion Criteria:\n\n1. Admission to neurological intensive care unit (NICU).\n2. Age ≥18 years old. Participants will be eligible if they meet both of these criteria.\n\nExclusion Criteria:\n\n1. Evidence of absolute renal impairment, which included Serum creatinine (SCR) ≥133 μmol\u002FL at admission, development of acute kidney injury (AKI) after admission, need for renal replacement therapy during hospitalization, renal related tests suggestive of renal disease, and previous history of renal replacement therapy or chronic kidney disease.\n2. Pregnant participants.\n3. Primary diagnosis is non-neurological disease.\n4. The height or weight of participants is not recorded in the medical record system.\n5. The frequency of SCR monitoring was less than 3 times. Participants who meet any of these criteria will be excluded.",{"count":274,"type":20},112,[59],"The goal of this clinical trial is to compare the clinical efficacy of individualized dosing based on the population pharmacokinetics (PK) model and empirical dosing of vancomycin in participants with severe infections.\n\nIt aims to answer whether individual vancomycin dosing based on population PK model is superior to empirical dosing in terms of clinical efficacy and safety.\n\nParticipants will be randomly divided into experimental group and control group. The experimental group will be guided by the population PK model for individual dosing, and the control group will be given empirical dosing. Demographic data, clinical characteristics of participants, and their trough concentrations (Cmin) and peak concentrations (Cmax) of vancomycin will be collected. Area under the concentration curve (AUC24) of participants will be calculated using the first-order PK equation.\n\nResearchers will compare experimental group and control group to see if individual vancomycin dosing based on population PK model is superior to empirical dosing in terms of clinical efficacy and safety.",[27],[279,280,256],"vancomycin","population pharmacokinetic model","2023-11-30",{"date":283,"type":38},"2023-12-08",{"date":285,"type":38},"2021-01-01",{"date":287,"type":20},"2024-12",{"name":289,"class":45},"Central South University",{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":294,"acronym":295,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":298,"conditions":299,"keywords":301,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":77},"100412442","phage-safety-cohort-study-100412442","NCT04650607","Phage Safety Cohort Study","PHA-SA-CO","Inclusion Criteria:\n\n* Patient 18 years of age or older with a serious infection treated at CRIOAc Lyon by phage therapy\n* Patient who did not object to participating in the study\n* Patients ayant un poids minimum de 46kg\n\nExclusion Criteria:\n\n* Patients under guardianship\u002Fcuratorship\n* Patients deprived of liberty\n* Pregnant or breastfeeding women",{"count":198,"type":20},"This cohort study aims to describe the adverse events related to the use of bacteriophages to treat serious infections, data from the literature being almost non-existent on this subject.",[300,27],"Prosthetic Joint Infection",[302,303,256,304],"phage","adverse event","compassionate treatment","2023-04-12",{"date":307,"type":38},"2023-04-13",{"date":309,"type":38},"2022-05-09",{"date":311,"type":20},"2028-05-09",{"name":265,"class":45}]