protocolSection identificationModule nctId: NCT06293677, orgStudyIdInfo id: 2023-01013, briefTitle: Adjustment of Antibiotic Dosage in Pediatric Oncology Patients With Febrile Neutropenia and Augmented Renal Clearance, acronym: DAR-ARC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire Vaudois, class: OTHER, collaborators name: Unisanté Centre universitaire de médecine générale et santé publique, collaborators name: FORCE Fondation Recherche sur le Cancer de l'Enfant, descriptionModule briefSummary: 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.The main questions this study aims to answer are, in these children:* Would higher doses of antibiotics result in better blood levels of antibiotics?* Would they have more sides effects with higher antibiotics dosages?* 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., conditionsModule conditions: Febrile Neutropenia, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Our study is an open-label, re-randomized controlled trial in multi-episodes settings. So the care team, researchers and patients will be informed of the allocation group. Patients will be able to participate in each episode of febrile neutropenia. At each inclusion the patient may be in a different group., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Dosage Adjustment Rules for Augmented Renal Clearance (DAR-ARC) for piperacillin-tazobactam and meropenem, interventions name: Standard dosages of piperacillin-tazobactam or meropenem, outcomesModule primaryOutcomes measure: Achievement of antibiotic concentration targets in the intervention group (1i) vs control groupe (1c), secondaryOutcomes measure: Achievement of antibiotic concentration targets in control group 2, secondaryOutcomes measure: Fever duration, secondaryOutcomes measure: Side effects of antibiotic therapy, secondaryOutcomes measure: Number of dosage adjustments required to achieve the target concentration, secondaryOutcomes measure: Difference between eGFR measured by creatinine-based Schwartz formula and other eGFR calculation formulas, eligibilityModule sex: ALL, minimumAge: 61 Days, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Centre Hospitelier Universitaire Vaudois (CHUV), city: Lausanne, state: Vaud, zip: 1011, country: Switzerland, contacts name: Margherita Plebani, role: CONTACT, phone: +41795563598, email: Margherita.Plebani@chuv.ch, contacts name: Pierre-Alex Crisinel, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.516, lon: 6.63282, hasResults: False