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

NCT07616635 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2026-06-01

No results posted yet for this study

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 .

Conditions

Interventions

DRUG

Fosfomycin

5000 mg 3 times a day

DRUG

ciprofloxacin

500 mg twice a day

Sponsors & Collaborators

  • Fundación para la Investigación Biosanitaria del Principado de Asturias

    lead OTHER

Principal Investigators

  • Teresa Bernal, MD OHD · Universidad de Oviedo

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-14
Primary Completion
2024-05-29
Completion
2024-12-01

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07616635 on ClinicalTrials.gov