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.

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Poitiers University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Febrile Neutropenia

Interventions

Type	Name	Description
DRUG	Placebo	The aim of the study is to validate the desescalation of the treatment to stop ciprofloxacin prescription that may not impact the outcome of the patients but add toxicity and antibiotics selection. Placebo will be administred in the experimental arm
DRUG	Amoxicillin Clavulanate	Will be administred to all patients
DRUG	Ciprofloxacin	Will be administred to patients in the standard of care arm

Timeline

• Start date: 2022-03-01
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2021-01-06
• Last updated: 2022-03-31