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A Trial of Fosfomycin vs Ciprofloxacin for Febrile Neutropenia (FOVOCIP)
Sponsor: Fundación para la Investigación Biosanitaria del Principado de Asturias
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
Fosfomycin
5000 mg 3 times a day
ciprofloxacin
500 mg twice a day
Locations (1)
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain