New antibiotic may replace standard infection prevention in blood cancer patients
NCT ID NCT07616635
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether fosfomycin, an older antibiotic, works as well as ciprofloxacin for preventing serious infections in people with blood cancers like leukemia or those receiving a stem cell transplant. 177 adults from 11 Spanish hospitals took part. The main goal was to see how many developed fever with low white blood cell counts. The results could offer a safer alternative to current prevention methods.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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177 people
The number who actually took part.
- Started
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Mar 2022
- Finished
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Dec 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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