Status:
RECRUITING
Adjustment of Antibiotic Dosage in Pediatric Oncology Patients With Febrile Neutropenia and Augmented Renal Clearance
Lead Sponsor:
Centre Hospitalier Universitaire Vaudois
Collaborating Sponsors:
Unisanté Centre universitaire de médecine générale et santé publique
FORCE Fondation Recherche sur le Cancer de l'Enfant
Conditions:
Febrile Neutropenia
Eligibility:
All Genders
61-18 years
Phase:
PHASE4
Brief Summary
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 blo...
Detailed Description
Background and Rationale In pediatric cancer patients, Augmented Renal Clearance (ARC) is a common factor that affects outcomes. Febrile neutropenia, a frequent occurrence during cancer treatment, req...
Eligibility Criteria
Patients' inclusion criteria
- Oncologic patients aged 2 months to 17 years (older than 60 days and younger than 18 years),
- High probability of febrile neutropenia during the study period
- Written informed consent from parents and adolescents older than 14 years
Patients' exclusion criteria
- Neutropenia not related to cancer and/or chemotherapy
- Refusal to participate
- Non-French speaking parents/patients older than 11 years old
- Absence of febrile neutropenia or agranulocytosis during the study period (secondary exclusion)
Febrile neutropenia episodes inclusion criteria
-
Febrile neutropenia or agranulocytosis defined as:
- Neutropenia: absolute neutrophils <500 cells/µL or agranulocytosis: absolute neutrophils <100 cells/µL or patients expected to be neutropenic in the next 24 hours due to ongoing chemotherapy
- body temperature (tympanic or axillary) ≥38°C during at least one hour or a single T ≥38.5°C
-
At least 2 weeks after the end of the previous antibiotic treatment for another included episode of febrile neutropenia.
Febrile neutropenia episodes exclusion criteria:
- Severe renal failure (GFR<15 mL/min/1.73 m²)
- Pregnancy
- 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)
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06293677
Start Date
March 1 2024
End Date
March 1 2026
Last Update
July 11 2024
Active Locations (1)
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1
Centre Hospitelier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, Switzerland, 1011