drugset / Trial / NCT04698057

Amoxicillin-clavulanate Alone or in Combination With Ciprofloxacin in Low-Risk Febrile Neutropenic Adult Patients: A Prospective, Double-blind, Randomized, Non-Inferiority Multicenter, Phase III Clinical Trial.

NCT04698057

Phase 3 Withdrawn Poitiers University Hospital
RandomizedParallel-groupQuadruple-blindTreatment

Summary

In low risk neutropenic fever in cancer, standard of care is the association of amoxicillin clavulanate and ciprofloxacin. But in this population, the rate of fever related to infection is very low, leading to a overtreatment of the patients. The aim of this study is to validate a descalation of the antibiotherapy with safety concerns.

Timeline

Start
2022-03-01
Primary completion
2025-06-01
Completion
2025-06-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ciprofloxacin Small molecule 750 mg
Background Amoxicillin Other / unclassified 1 g

Indications