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COMPLETED
NCT07616635
PHASE3

A Trial of Fosfomycin vs Ciprofloxacin for Febrile Neutropenia (FOVOCIP)

Sponsor: Fundación para la Investigación Biosanitaria del Principado de Asturias

View on ClinicalTrials.gov

Summary

Prophylaxis with fluoroquinolones in high-risk neutropenic patients is currently under scrutiny due to their toxicity and the potential of selecting multirresistant bacteria. In this setting, the search for an alternative prophylactic drug is a priority. The FOVOCIP study aimed to evaluate the efficacy and safety of fosfomycin compared to ciprofloxacin in this population. This was a multicentre, randomised, phase-3, non-inferiority, open-label trial performed in 11 centres in Spain. Adults diagnosed with acute leukaemia or recipients of a Haematopoietic Stem Cell Transplant were randomised to receive oral fosfomycin or oral ciprofloxacin as prophylaxis. The primary endpoint was rate of febrile neutropenia. Secondary endpoints included safety, including microbiological safety and gut microbiota changes .

Official title: Fosfomycin Versus Ciprofloxacin for Febrile Neutropenia Prophylaxis in High-risk Haematological Patients (FOVOCIP): a Phase 3, Open-label, Multicentre, Randomised, Non-inferiority Trial.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

177

Start Date

2022-03-14

Completion Date

2024-12-01

Last Updated

2026-06-01

Healthy Volunteers

No

Interventions

DRUG

Fosfomycin

5000 mg 3 times a day

DRUG

ciprofloxacin

500 mg twice a day

Locations (1)

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain