Adjustment of Antibiotic Dosage in Pediatric Oncology Patients With Febrile Neutropenia and Augmented Renal Clearance

Launched by CENTRE HOSPITALIER UNIVERSITAIRE VAUDOIS · Feb 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how to adjust antibiotic doses for children with cancer who develop febrile neutropenia, a condition where they have a fever and low white blood cell counts after chemotherapy. Chemotherapy can weaken the immune system, making these children more vulnerable to infections. In some cases, their kidneys process antibiotics more quickly than usual, which might mean they don’t get enough medication to fight off infections effectively. The trial will look at whether giving higher doses of two specific antibiotics—piperacillin-tazobactam and meropenem—can help these children maintain better levels of medication in their blood, while also checking if higher doses lead to more side effects or quicker recovery.

To be eligible for this trial, children aged between 2 months and 17 years who are likely to experience febrile neutropenia due to their cancer treatment may participate. Parents or guardians will need to provide written consent. Once enrolled, participants will receive a blood test to check their kidney function. Depending on the results, some children will receive standard doses, while others will get higher doses of antibiotics. Throughout the study, their antibiotic levels will be regularly monitored, allowing doctors to adjust the doses if necessary. This research aims to find the best way to treat infections in these vulnerable patients.

Gender

ALL

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)