drugset / Trial / NCT04948463

Early Versus Late Stopping of Antibiotics in Children With Cancer and High-risk Febrile Neutropenia

NCT04948463

Phase 4 Completed 55 enrolled Murdoch Childrens Research Institute
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomised controlled trial will determine the non-inferiority of stopping empiric antibiotics prior to absolute neutrophil count (ANC) recovery (Early Stopping) versus stopping antibiotics upon ANC recovery (Standard of Care/ Late Stopping) , in children with cancer and high-risk febrile neutropenia (FN).

Timeline

Start
2021-11-15
Primary completion
2025-12-17
Completion
2025-12-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Amikacin Small molecule 18 mg/kg
Subject Amikacin Small molecule 22.5 mg/kg
Subject Cefepime Small molecule 50 mg/kg
Subject Ceftazidime Small molecule 50 mg/kg
Subject Ciprofloxacin Small molecule 10 mg/kg
Subject Piperacillin Small molecule 100 mg/kg
Subject Tazobactam Small molecule 100 mg/kg
Subject Vancomycin Other / unclassified 15 mg/kg

Indications