[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pediatric-immuno-hematology-department\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pediatric-immuno-hematology-department":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100250488","population-pharmacokinetics-of-anti-infectives-in-critically-ill-children-100250488",false,"NCT02539407","Population Pharmacokinetics of Anti-infectives in Critically Ill Children","Population Pharmacokinetics and Rationalization of Anti-infectives Administration in Critically Ill Children","OPTIMOME","Inclusion Criteria:\n\n* Minor patient requiring the administration of an anti-infective belonging to the following classes : β-lactam antibiotics; aminoglycosides, glycopeptides; fluoroquinolones; other antibiotics (daptomycin, rifampin, trimethoprim, sulfamethoxazole, clarithromycin); fungal; antivirals, during its follow-up or hospitalization\n\nExclusion Criteria:\n\n* Patient and parents having notified to the doctor that they refuse data recovery.","ALL","1 Day","18 Years",{"count":21,"type":22},3000,"ESTIMATED","OBSERVATIONAL","Concentrations and effects of anti-infectives in critically ill children are unpredictable and the risk of under-exposure may be associated with poor clinical outcomes. In addition, between-subject variability (BSV) is known to be substantial in critically ill children. Rationalisation of anti-infectives in children is therefore desirable.\n\nThe investigators aim to investigate, using a population approach, the pharmacokinetics (PK) and pharmacodynamics (PD) of anti-infectives including PK\u002FPD targets (fT(%) \\> minimal inhibitory concentration (MIC)) and PD endpoints (clinical outcomes) in critically ill children. Covariates The effects of covariates on anti-infectives PK and PK\u002FPDs are investigated in order to better explain the BSV and to ultimately suggest individualized dosage regimens.\n\nIt will be a prospective PK study including 11 anti-infectives antibiotics. Six blood samples were taken from each patient during dosing interval. The primary PK\u002F PD targets were anti-infectives concentrations above the MIC of the pathogen at both 50% (50% f T\\>MIC) and 100% (100% f T\\>MIC) of the dosing interval. The investigators used skewed logistic regression to describe the effect of anti-infectives exposure on patient outcome.",[26,27],"Pediatric Intensive Care Unit","Pediatric Immuno-hematology Department",[29,30,31,32,33,34,35],"β-lactam antibiotics","Children","Anti-infectives","Aminoglycosides, glycopeptides","Fluoroquinolone","Fungal","Antiviral","RECRUITING","2025-11-17",{"date":39,"type":40},"2025-11-20","ACTUAL",{"date":42,"type":40},"2015-09-11",{"date":44,"type":22},"2028-12",{"name":46,"class":47},"Assistance Publique - Hôpitaux de Paris","OTHER"]