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

NCT07616635 | Completed Phase 3 DMC

• 2 other identifiers: PI21/1590 AES 20212021-000354-25
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

Brief 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

Haematopoietic Stem Cell Transplantation; Acute Leukemia

Outcome Measures

Primary Outcomes (1)

• Febrile neutropenia

  Fever was defined as a single oral temperature of 38.3 °C or a temperature of 38 °C sustained over a 1-h period. If the patient was receiving any medication with a high probability of inducing fever or had been previously transfused, at least a positive culture or an infected site was required to be ascribed to infection.

  The primary endpoint will be evaluated from the first day of chemotherapy until the absolute neutrophil count has reached >0.5x109/L, for a maximum of 60 days in case ANC >0.5x109/L is not reached.

Study Arms (2)

Standard prophylaxis

ACTIVE COMPARATOR

Drug: ciprofloxacin

Alternative prophilaxis

EXPERIMENTAL

500 mg three times a day

Drug: Fosfomycin

Interventions

Fosfomycin DRUG

5000 mg 3 times a day

Alternative prophilaxis

ciprofloxacin DRUG

500 mg twice a day

Standard prophylaxis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Hypersensitivity to fluoroquinolones or fosfomycin.
• Treatment with broad-spectrum antimicrobial therapy within 4 weeks of the first study treatment.
• Intensive chemotherapy or previous haematopoietic stem cell transplantation. Treatment with hydroxyurea or corticosteroids used to control white blood cell count is permitted.
• Fever of infectious origin or documented infection within 4 weeks of the first study treatment.

Sponsors & Collaborators

• Fundación para la Investigación Biosanitaria del Principado de Asturias: lead

Study Sites (1)

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

Location

MeSH Terms

Interventions

Fosfomycin; Ciprofloxacin

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Teresa Bernal, MD OHD

  Universidad de Oviedo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: June 1, 2026
• Study Start: March 14, 2022
• Primary Completion: May 29, 2024
• Study Completion: December 1, 2024
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

ES (1)