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

May 27, 2026 updated by: Fundación para la Investigación Biosanitaria del Principado de Asturias

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

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 .

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
177

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33011
        • Hospital Universitario Central de Asturias

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

  1. Subjects must be able to understand the study procedures, comply with them, and provide written informed consent prior to any specific study procedures.
  2. Adult subjects ≥ 18 years of age diagnosed with acute leukaemia who are scheduled to receive a first course of intensive chemotherapy.

  3. Adult subjects ≥ 18 years of age who are candidates for a first allogeneic haematopoietic stem cell transplant with myeloablative conditioning or adult subjects ≥ 18 years of age who are candidates for a first allogeneic haematopoietic stem cell transplant with reduced-intensity conditioning or an autologous haematopoietic stem cell transplant, provided that at least one of the following risk factors for infection is present:

    1. Functional status (Eastern Cooperative Oncology Group, ECOG) ≥2.
    2. Expected grade 3-4 mucositis.
    3. Age ≥65 years.
    4. Comorbidity index (HCTI) ≥3.
    5. Serum albumin < 35 g/L.
    6. Active or refractory neoplasia at the time of stem cell transplantation.
    7. Total dose of etoposide > 500 mg/m2.
    8. Total dose of cytarabine > 1 g/m2.
  4. Functional status (Eastern Cooperative Oncology Group, ECOG) from 0 to 3.

  5. Adequate organ function defined as:

    • Liver: bilirubin, alkaline phosphatase or SGOT < 3 times the upper normal limit (unless attributable to tumour activity).
    • Renal: creatinine ≤ 250 μmol/l (2.5 mg/dL) (unless attributable to leukemic infiltration).
  6. Life expectancy greater than 3 months.
  7. Women of childbearing age must not be pregnant or breastfeeding and must have a negative pregnancy test at the time of screening. Women of childbearing age and men with female partners of childbearing age must commit to using two highly effective forms of contraception and must agree not to become pregnant or father a child while receiving any study therapy and for at least 3 months after completing treatment.

Exclusion criteria

Patients who meet any of the following exclusion criteria will not be eligible for inclusion in this study:

  1. Hypersensitivity to fluoroquinolones or fosfomycin.
  2. Treatment with broad-spectrum antimicrobial therapy within 4 weeks of the first study treatment.
  3. Intensive chemotherapy or previous haematopoietic stem cell transplantation. Treatment with hydroxyurea or corticosteroids used to control white blood cell count is permitted.
  4. Fever of infectious origin or documented infection within 4 weeks of the first study treatment.
  5. Presence of any serious psychiatric illness or physical condition that, in the opinion of the physicians, contraindicates the patient's inclusion in the clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard prophylaxis
Drug: ciprofloxacin
500 mg twice a day
Experimental: Alternative prophilaxis
500 mg three times a day
Drug: Fosfomycin
5000 mg 3 times a day

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Febrile neutropenia
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundación para la Investigación Biosanitaria del Principado de Asturias

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Teresa Bernal, MD OHD, Universidad de Oviedo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 14, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 29, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PI21/1590 AES 2021
  • 2021-000354-25 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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