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

  • STATUS
    Recruiting
  • End date
    Mar 14, 2023
  • participants needed
    156
  • sponsor
    Fundación para la Investigación Biosanitaria del Principado de Asturias
Updated on 20 April 2022

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 transplant.

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 acute leukemia who are treated with intensive chemotherapy and/or are recipients of a hematopoietic stem cell transplant.

Non-inferiority design.

156 patients will be recruited: 78 in each arm

Details
Condition Febrile Neutropenia
Treatment Fosfomycin Calcium
Clinical Study IdentifierNCT05311254
SponsorFundación para la Investigación Biosanitaria del Principado de Asturias
Last Modified on20 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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