[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538656":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":35,"centralContacts":39,"locations":48,"responsibleParty":67,"collaborators":70,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":30,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":51,"whyStopped":30,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Centre Hospitalier Universitaire Vaudois","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Group 1c","ACTIVE_COMPARATOR","Group 1c includes patients with augmented renal clearance (ARC) who have been randomized to receive a standard dosage of antibiotic (méropenem or piperacilline-tazobactam)",[13],"Drug: Standard dosages of piperacillin-tazobactam or meropenem",{"label":15,"type":16,"description":17,"interventionNames":18},"Intervention DAR-ARC Group 1i","EXPERIMENTAL","Group 1i (DAR-ARC) includes patients with ARC who have been randomized to receive an experimental dosage of antibiotic (méropenem or piperacilline-tazobactam)",[19],"Drug: Dosage Adjustment Rules for Augmented Renal Clearance (DAR-ARC) for piperacillin-tazobactam and meropenem",{"label":21,"type":10,"description":22,"interventionNames":23},"Control Group 2","Control Group 2 includes patients with normal or decreased renal function who will receive standard dosage of antibiotic (méropenem or piperacilline-tazobactam)",[13],[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Dosage Adjustment Rules for Augmented Renal Clearance (DAR-ARC) for piperacillin-tazobactam and meropenem","Meropenem dosages according to eGFR \\[mL\u002Fmin\u002F1.73 m²\\] :\n\neGFR 120-149 : 40 mg\u002Fkg q6 h eGFR 150-199 : 30 mg\u002Fkg q4h eGFR 200-299 : 40 mg\u002Fkg q4h eGFR \\>\u002F= 300 : 40 mg\u002Fkg q4h\n\nPiperacillin-tazobatam dosages according to eGFR \\[mL\u002Fmin\u002F1.73 m²\\] :\n\neGFR 120-149 : 150 mg\u002Fkg q6 h eGFR 150-199 : 120 mg\u002Fkg q4h eGFR 200-299 : 150 mg\u002Fkg q4h eGFR \\>\u002F= 300 : 180 mg\u002Fkg q4h\n\nThe maximum doses for the antibiotic prescription before the first drug monitoring will be 2gr of MER every 4 hours and 4gr of PIP every 4 hours.\n\nThe duration of infusion will be set to 2 h.",[15],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Standard dosages of piperacillin-tazobactam or meropenem","Meropenem dosages according to eGFR \\[mL\u002Fmin\u002F1.73 m²\\] :\n\neGFR\\> 50 : 40mg\u002Fkg q8h eGFR 25-49 : 40mg\u002Fkg q12h eGFR 15-24 : 20mg\u002Fkg q12h\n\nPiperacillin-tazobactam :\n\neGFR \\>50 : 100mg\u002Fkg q6h eGFR 20-49 : 50mg\u002Fkg q6h eGFR 15-29 : 50 mg\u002Fkg q8h",[9,21],[36],{"name":37,"affiliation":5,"role":38},"Pierre-Alex Crisinel","PRINCIPAL_INVESTIGATOR",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":30,"email":44},"Margherita Plebani","CONTACT","+41(0)795563598","Margherita.Plebani@chuv.ch",{"name":37,"role":42,"phone":46,"phoneExt":30,"email":47},"+41(0)795568627","pierre-alex.crisinel@chuv.ch",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Centre Hospitelier Universitaire Vaudois (CHUV)","RECRUITING","Lausanne","Canton of Vaud","1011","Switzerland","CH",{"type":58,"coordinates":59},"Point",[60,61],6.63282,46.516,{"lat":61,"lon":60},[64,66],{"name":41,"role":42,"phone":65,"phoneExt":30,"email":44},"+41795563598",{"name":37,"role":38,"phone":30,"phoneExt":30,"email":30},{"type":38,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Pierre Alex Crisinel","Head of the Unit of Pediatric Infectious Diseases and Vaccinology",[71,74],{"name":72,"class":73},"Unisanté Centre universitaire de médecine générale et santé publique","UNKNOWN",{"name":75,"class":73},"FORCE Fondation Recherche sur le Cancer de l'Enfant","100538656","phase-4-adjustment-of-antibiotic-dosage-in-pediatric-oncology-patients-with-febrile-neutropenia-and-augmented-renal-clearance-100538656",false,"NCT06293677","Adjustment of Antibiotic Dosage in Pediatric Oncology Patients With Febrile Neutropenia and Augmented Renal Clearance","Upwards Initial Adjustment of Wide-Spectrum Antibiotic Dosage in Pediatric Oncology Patients With Febrile Neutropenia and Suspected Augmented Renal Clearance: A Randomized Controlled Trial With Therapeutic Drug Monitoring","DAR-ARC","Patients' inclusion criteria\n\n* Oncologic patients aged 2 months to 17 years (older than 60 days and younger than 18 years),\n* High probability of febrile neutropenia during the study period\n* Written informed consent from parents and adolescents older than 14 years\n\nPatients' exclusion criteria\n\n* Neutropenia not related to cancer and\u002For chemotherapy\n* Refusal to participate\n* Non-French speaking parents\u002Fpatients older than 11 years old\n* Absence of febrile neutropenia or agranulocytosis during the study period (secondary exclusion)\n\nFebrile neutropenia episodes inclusion criteria\n\n* Febrile neutropenia or agranulocytosis defined as:\n\n  * Neutropenia: absolute neutrophils \\<500 cells\u002FµL or agranulocytosis: absolute neutrophils \\<100 cells\u002FµL or patients expected to be neutropenic in the next 24 hours due to ongoing chemotherapy\n  * body temperature (tympanic or axillary) ≥38°C during at least one hour or a single T ≥38.5°C\n* At least 2 weeks after the end of the previous antibiotic treatment for another included episode of febrile neutropenia.\n\nFebrile neutropenia episodes exclusion criteria:\n\n* Severe renal failure (GFR\\<15 mL\u002Fmin\u002F1.73 m²)\n* Pregnancy\n* Inability to obtain the first therapeutic drug monitoring (TDM) result within 72 hours of sampling (e.g. admission before or during public holidays laboratory closure)","ALL","61 Days","18 Years",{"count":88,"type":89},30,"ESTIMATED","INTERVENTIONAL",[92],"PHASE4","This clinical trial focuses on children with cancer who face infections after receiving chemotherapy. Chemotherapy affects the bone marrow, leading to a decrease in the production of certain white blood cells, particularly those that defend against bacterial infections (neutrophils). One significant concern is febrile neutropenia, where children experience a fever during a period of low white blood cell count. This condition often results from bacterial infections, necessitating prompt wide-spectrum antibiotic treatment. However, some children eliminate antibiotics in the urine too quickly during febrile neutropenia. Their kidneys function more than they normally do (renal hyperfiltration). This can lead to insufficient exposure to antibiotics to control the infection. The current standard antibiotic regimens do not account for this variable elimination rate. In this study we focus on two antibiotics used in this context: piperacillin-tazobactam and meropenem.\n\nThe main questions this study aims to answer are, in these children:\n\n* Would higher doses of antibiotics result in better blood levels of antibiotics?\n* Would they have more sides effects with higher antibiotics dosages?\n* Would they recover more quickly with higher antibiotic doses? All patients will undergo a blood test upon hospital arrival, including an assessment of renal function. If renal function is normal or diminished, the patient will receive the standard antibiotic dose. Children with increased renal function will be randomly assigned to two groups during each episode of febrile neutropenia. One group will receive standard antibiotic dosages, while the other will receive higher doses to compensate for renal hyperfiltration. Throughout the study, antibiotic levels in the blood will be monitored for all patients. This monitoring will determine if target concentrations can be achieved more quickly with experimental dosages and will allow doctors to readjust the doses if needed.",[95],"Febrile Neutropenia",[97,98,99,100,101,102,103],"Febrile neutropenia","Augmented Renal Clearance","Pediatric cancer","Therapeutic Drug monitoring TDM","Children","Wilde-spectrum antibiotic dosage","Glomerular filtration rate GFR","2024-07-10",{"date":106,"type":107},"2024-07-11","ACTUAL",{"date":109,"type":107},"2024-03-01",{"date":111,"type":89},"2026-03",{"name":5,"class":6},1]