[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100316784":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":19,"locations":27,"responsibleParty":39,"collaborators":41,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":46,"sex":52,"minAge":19,"maxAge":53,"enrollmentInfo":54,"targetDuration":19,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":67,"whyStopped":68,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"University Hospital, Lille","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"pharmacokinetic device","EXPERIMENTAL","MON4STRAT system",[13],"Device: pharmacokinetic device",[15,20],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","MON4STRAT system: bed-side pharmacokinetic device for drug concentration measurement",[9],null,{"type":16,"name":9,"description":21,"armGroupLabels":22,"otherNames":19},"High performance liquid chromatography, (HPLC), the reference methods HLPC tandem mass spectrometry or Ultraviolet are using",[9],[24],{"name":25,"affiliation":5,"role":26},"François DUBOS, MD,PhD","PRINCIPAL_INVESTIGATOR",[28],{"facility":29,"status":19,"city":30,"state":19,"zip":19,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":19},"Hôpital Roger Salengro, CHU","Lille","France","FR",{"type":34,"coordinates":35},"Point",[36,37],3.05512,50.63391,{"lat":37,"lon":36},{"type":40,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[42],{"name":43,"class":6},"European Commission","100316784","bedside-therapeutic-monitoring-of--lactam-levels-in-newborns-children-and-adolescents-admitted-to-intensive-care-100316784",false,"NCT03404089","Bedside Therapeutic Monitoring of β-Lactam Levels in Newborns, Children and Adolescents Admitted to Intensive Care.","Bedside Therapeutic Monitoring of β-Lactam Levels in Newborns, Children and Adolescents Admitted to Intensive Care: Study of a Pharmacokinetics Monitoring Method.","MON4STRAT","Inclusion Criteria:\n\n* Age younger than 18 years\n* Newborns (preterm or not) in neonatal intensive care\n* Infants, children, and adolescents in pediatric intensive care\n* Clinically suspected or microbiologically proven sepsis that might be associated with ventilator-associated pneumonia or otherwise associated with health care\n* Need for antibiotic treatment by piperacillin-tazobactam, ceftazidime, or meropenem of intermittent administration\n* Informed consent form signed by parents\u002Fguardian\n* Informed consent form signed by patients old enough to understand.\n\nExclusion Criteria:\n\n* Process for active limitation of treatment underway\n* Suspected or known hypersensitivity to studied beta-lactams\n* Renal failure, defined as serum creatinine \\> 1.5 mg\u002Fdl or urine production \\\u003C 0.3 ml\u002Fkg for 24 h or anuria for 12 h.\n* Co-administration of two β-lactam antibiotics\n* Cystic fibrosis\n* No national health insurance coverage in French center\n* Family unable to understand study-related information due to language or other communication issues\n* No consent obtained","ALL","18 Years",{"count":55,"type":56},13,"ACTUAL","INTERVENTIONAL",[59],"NA","This study evaluate the capacity of the MON4STRAT device for drug monitoring of β- lactam antibiotic concentrations in newborns, children, and adolescents admitted in intensive care units with a health care-associated infection.",[62],"Intensive Care Unit Syndrome",[64,65,66,50],"device drug monitoring","β-lactam antibiotic","health care-associated infection","TERMINATED","insufficient inclusions","2023-01-17",{"date":71,"type":56},"2023-01-19",{"date":73,"type":56},"2018-04-18",{"date":75,"type":56},"2019-06-30",{"name":5,"class":6},1]