Adjusting antibiotic doses for children with cancer and infections
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
This study is testing how to adjust antibiotic doses for children with cancer who have infections to make sure they get the right amount of medicine when their kidneys clear it from their bodies too quickly.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 61 Days to 18 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Vaudois Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Lausanne, Canton of Vaud) |
| Trial ID | NCT06293677 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates how to adjust antibiotic dosages for pediatric oncology patients experiencing febrile neutropenia, a condition characterized by fever and low white blood cell counts due to chemotherapy. The study focuses on children who may eliminate antibiotics too quickly due to augmented renal clearance, which can lead to insufficient antibiotic levels in the bloodstream. By evaluating different methods for estimating renal function, the trial aims to optimize antibiotic treatment with piperacillin-tazobactam and meropenem. The study will involve three treatment arms to compare standard dosages with adjusted dosages based on renal function assessments.
Who should consider this trial
Good fit: Ideal candidates are pediatric oncology patients aged 2 months to 17 years who are likely to experience febrile neutropenia during their treatment.
Not a fit: Patients with neutropenia not related to cancer or chemotherapy, or those who refuse to participate, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective antibiotic treatments for children with cancer, reducing the risk of infections and improving patient outcomes.
How similar studies have performed: While studies on antibiotic dosing in pediatric patients exist, this specific approach addressing augmented renal clearance in oncology patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Lausanne, Canton of Vaud
- Centre Hospitelier Universitaire Vaudois (CHUV) — Lausanne, Canton of Vaud, Switzerland (Recruiting)
Study contacts
- Principal investigator: Pierre-Alex Crisinel — Centre Hospitalier Universitaire Vaudois
- Study coordinator: Margherita Plebani
- Email: Margherita.Plebani@chuv.ch
- Phone: +41(0)795563598
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.