[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100250488":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":18,"centralContacts":27,"locations":36,"responsibleParty":51,"collaborators":53,"id":56,"slug":10,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":10,"studyType":69,"phases":10,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Anti-infectives",null,"Anti-infectives of the following : β-lactam antibiotics, Aminoglycosides, Glycopeptides, Fluoroquinolone, Daptomycin, Rifampin, Trimethoprim, Sulfamethoxazole, Clarithromycin, Fungal, Antiviral\n\nPharmacokinetics",[13],"Other: Pharmacokinetics",[15],{"type":6,"name":16,"description":10,"armGroupLabels":17,"otherNames":10},"Pharmacokinetics",[9],[19,23],{"name":20,"affiliation":21,"role":22},"Oualha Mehdi, MD,PhD","Hospital Necker - Enfants Malades","PRINCIPAL_INVESTIGATOR",{"name":24,"affiliation":25,"role":26},"Jean-Marc Treluyer, MD, PhD","EA08 Paris Descartes Pharmacologie et Evaluation des thérapeutiques chez l'enfant et la femme enceinte","STUDY_CHAIR",[28,32],{"name":20,"role":29,"phone":30,"phoneExt":10,"email":31},"CONTACT","+33171196082","mehdi.oualha@nck.aphp.fr",{"name":33,"role":29,"phone":34,"phoneExt":10,"email":35},"Laure Choupeaux","+33 1 44 38 17 11","laure.choupeaux@aphp.fr",[37],{"facility":38,"status":39,"city":40,"state":10,"zip":41,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Hospital Necker - Enfants Malades (Public Hospitals of Paris)","RECRUITING","Paris","75015","France",{"type":44,"coordinates":45},"Point",[46,47],2.3488,48.85341,{"lat":47,"lon":46},[50],{"name":20,"role":29,"phone":30,"phoneExt":10,"email":10},{"type":52,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[54],{"name":55,"class":6},"URC-CIC Paris Descartes Necker Cochin","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":67,"type":68},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.",[72,73],"Pediatric Intensive Care Unit","Pediatric Immuno-hematology Department",[75,76,9,77,78,79,80],"β-lactam antibiotics","Children","Aminoglycosides, glycopeptides","Fluoroquinolone","Fungal","Antiviral","2025-11-17",{"date":83,"type":84},"2025-11-20","ACTUAL",{"date":86,"type":84},"2015-09-11",{"date":88,"type":68},"2028-12",{"name":5,"class":6},1]