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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Centre Hospitelier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, Switzerland, 1011