Adjusting antibiotic doses for children with cancer and infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Personalized antibiotic duration for high-risk febrile neutropenia with Gram-negative bloodstream infection

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.