Status:
UNKNOWN
A Trial of Fosfomycin vs Ciprofloxacin for Febrile Neutropenia
Lead Sponsor:
Fundación para la Investigación Biosanitaria del Principado de Asturias
Collaborating Sponsors:
Instituto de Investigación Marqués de Valdecilla
Instituto de Salud Carlos III
Conditions:
Febrile Neutropenia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Randomized phase 3 trial to compare efficacy and safety of oral fosfomycin versus ciprofloxacin to prevent febrile neutropenia in patients with acute leukemia or recipients of hematopoietic stem cell ...
Detailed Description
Multicenter, prospective, randomized, open label phase III trial to assess the efficacy and safety of oral fosfomycin vs. oral ciprofloxacin in the prevention of febrile neutropenia in patients with a...
Eligibility Criteria
Inclusion
- Subjects who are able to understand study procedures, comply with them, and provide written informed consent before any study-specific procedure.
- Adult subjects ≥ 18 years of age with acute leukemia diagnosis who are going to receive their first intensive chemotherapy cycle or adult subjects ≥ 18 years of age who are candidates to receive a first stem cell transplant.
- Expected neutropenia 100x109/L lasting at least seven days. In case of expected neutropenia range 100-500x109/L lasting seven days or more, at least one of the following risk factors for infection must be present:
- Performance status (Eastern Cooperative Oncology Group, ECOG) ≥2.
- Expected mucositis grade 3-4.
- Age ≥65 years.
- Comorbidity Index (HCTI) ≥3.
- Serum albumin\< 35 g/L.
- Total dose of etoposide \> 500 mg/m2
- Total dose of cytarabine \> 1 g/m2
- Active or refractory neoplasia at the moment of stem cell transplant.
- Performance status (Eastern Cooperative Oncology Group, ECOG) of 0 to 3.
- Adequate organ function defined as:
- Liver: bilirubin, alkaline phosphatase, or SGOT \< 3 times the upper normal limit (unless it is attributable to tumor activity).
- Renal : creatinine ≤ 250 μmol/l (2.5 mg/dL) (unless it is attributable to AML activity).
- Life expectancy higher than 3 months.
- Women of child-bearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of child-bearing potential and men with female partners of child-bearing potential must agree to practice 2 highly effective contraceptive measures of birth control 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
- Hypersensitivity to fluoroquinolones or fosfomycin.
- Treatment with broad spectrum antimicrobial therapy within 4 weeks of first study treatment.
- Prior Intensive chemotherapy or stem cell transplant. Treatment with hydroxyurea or corticosteroids used to control white blood cell counts are permitted.
- Fever of infectious origin or documented infection within 4 weeks of first study treatment.
- Presence of any severe psychiatric disease or physical condition that, according to the physicians criteria, contraindicates the inclusion of the patient into the clinical trial.
- Subjects that have participated previously in this study
Key Trial Info
Start Date :
March 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 14 2024
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT05311254
Start Date
March 14 2022
End Date
March 14 2024
Last Update
September 14 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Instituto de Investigación Sanitaria del Principado de Asturias
Oviedo, Principality of Asturias, Spain, 33011