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A multicenter randomized trial of fosfomycin versus ciprofloxacin for febrile neutropenia in hematologic patients: efficacy and microbiologic safety.
EU CTIS ID: 2024-520336-14-00
What this study is testing
To demonstrate non-inferiority in efficacy of oral fosfomycin versus oral ciprofloxacin in preventing febrile neutropenia in patients with acute leukemia treated with intensive chemotherapy and/or recipients of hematopoietic stem cell transplantation hematopoietic stem cell transplantation.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subjects must be able to understand the study procedures, comply with them, and give written informed consent prior to any specific study procedure.
- Adult subjects ≥ 18 years of age with a diagnosis of acute leukemia who are to receive their first course of chemotherapy or adult subjects ≥ 18 years of age who are candidates for a first stem cell transplant.
- Expected neutropenia of 100x109/L lasting at least seven days. In the case of an expected range of 100-500x109/L neutropenia lasting seven days or longer, at least one of the following risk factors for infection must be present:
- b. Expected grade 3-4 mucositis. c. Age ≥65 years. d. Comorbidity index (HCTI) ≥3. e. Serum albumin< 35 g/L. f. Total dose of etoposide > 500 mg/m2. g. Total dose of cytarabine > 1 g/m2. h. Active or refractory neoplasia at the time of stem cell transplantation.
- Performance status (Eastern Cooperative Oncology Group, ECOG) of 0 to 3.
- Adequate organ function defined as: Adequate organ function defined as: - Liver : bilirubin, alkaline phosphatase or SGOT < 3 times the upper limit of normal (unless attributable to tumor activity). - Renal : creatinine ≤ 250 μmol/l (2.5 mg/dL) (unless attributable to AML activity).
You likely can't join if
- Hypersensitivity to fluoroquinolones or fosfomycin.
- Treatment with broad-spectrum antimicrobial therapy within 4 weeks of the first study treatment.
- Prior intensive chemotherapy or stem cell transplantation. Treatment with hydroxyurea or corticosteroids used to control white blood cell count is allowed
- Fever of infectious origin or documented infection within 4 weeks of first study treatment
- Presence of any serious psychiatric illness or physical condition that, in the judgment of the physicians, contraindicates the patient's inclusion in the clinical trial.
See the full eligibility criteria
- Subjects must be able to understand the study procedures, comply with them, and give written informed consent prior to any specific study procedure.
- Adult subjects ≥ 18 years of age with a diagnosis of acute leukemia who are to receive their first course of chemotherapy or adult subjects ≥ 18 years of age who are candidates for a first stem cell transplant.
- Expected neutropenia of 100x109/L lasting at least seven days. In the case of an expected range of 100-500x109/L neutropenia lasting seven days or longer, at least one of the following risk factors for infection must be present:
- b. Expected grade 3-4 mucositis. c. Age ≥65 years. d. Comorbidity index (HCTI) ≥3. e. Serum albumin< 35 g/L. f. Total dose of etoposide > 500 mg/m2. g. Total dose of cytarabine > 1 g/m2. h. Active or refractory neoplasia at the time of stem cell transplantation.
- Performance status (Eastern Cooperative Oncology Group, ECOG) of 0 to 3.
- Adequate organ function defined as: Adequate organ function defined as: - Liver : bilirubin, alkaline phosphatase or SGOT < 3 times the upper limit of normal (unless attributable to tumor activity). - Renal : creatinine ≤ 250 μmol/l (2.5 mg/dL) (unless attributable to AML activity).
- Life expectancy greater than 3 months
- Women of childbearing age should not be pregnant or breastfeeding and should have a negative pregnancy test at the time of screening. Women of childbearing age and men with female partners of childbearing age must agree to practice 2 highly effective contraceptive measures and must agree not to become pregnant or father a child while receiving any study therapy and for at least 3 months after completion of treatment.
- Hypersensitivity to fluoroquinolones or fosfomycin.
- Treatment with broad-spectrum antimicrobial therapy within 4 weeks of the first study treatment.
- Prior intensive chemotherapy or stem cell transplantation. Treatment with hydroxyurea or corticosteroids used to control white blood cell count is allowed
- Fever of infectious origin or documented infection within 4 weeks of first study treatment
- Presence of any serious psychiatric illness or physical condition that, in the judgment of the physicians, contraindicates the patient's inclusion in the clinical trial.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.