Haematopoietic Stem Cell TransplantationPhase 3FOVOCIPNCT07616635
A Trial of Fosfomycin vs Ciprofloxacin for Febrile Neutropenia (FOVOCIP)
A Phase 3 study testing Fosfomycin and ciprofloxacin in people with Haematopoietic Stem Cell Transplantation and Acute Leukemia, run by Fundación para la Investigación Biosanitaria del Principado de Asturias at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haematopoietic Stem Cell Transplantation, Acute Leukemia
- What is being tested?
- Fosfomycin and ciprofloxacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteSpain
- Study dates
- 14 Mar 2022to 1 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients who meet any of the following exclusion criteria will not be eligible for inclusion in this study:
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
About this study
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.
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 .
- Being tested
- Fosfomycin, ciprofloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FosfomycinDrug
5000 mg 3 times a day
ciprofloxacinDrug
500 mg twice a day
| Study group | Role | What they receive |
|---|---|---|
| Standard prophylaxis | Active comparator | Not described Receives: Drug: ciprofloxacin |
| Alternative prophilaxis | Experimental | 500 mg three times a day Receives: Drug: Fosfomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start14 Mar 2022
- Primary completion29 May 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación Biosanitaria del Principado de Asturias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teresa Bernal, MD OHD, Principal investigator, Universidad de Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616635
- Sponsor's protocol ID
- PI21/1590 AES 2021
- Other IDs
- 2021-000354-25
- Acronym
- FOVOCIP
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07616635
- Acronym / sponsor ID
- FOVOCIP / PI21/1590 AES 2021
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Fundación para la Investigación Biosanitaria del Principado de AsturiasUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 29 May 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard prophylaxis | Active comparator | Drug: ciprofloxacin |
| Alternative prophilaxis | Experimental | Drug: Fosfomycin500 mg three times a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Patients who meet any of the following exclusion criteria will not be eligible for inclusion in this study:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fosfomycin5000 mg 3 times a day | Drug | Alternative prophilaxis |
| ciprofloxacin500 mg twice a day | Drug | Standard prophylaxis |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teresa Bernal, MD OHD principal investigator
Universidad de Oviedo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fosfomycin and ciprofloxacin in people with Haematopoietic Stem Cell Transplantation and Acute Leukemia, run by Fundación para la Investigación Biosanitaria del Principado de Asturias at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.