NCT05311254

A Trial of Fosfomycin vs Ciprofloxacin for Febrile Neutropenia

A Multicenter Randomized Trial of Fosfomycin vs Ciprofloxacin for Febrile Neutropenia in Hematological Patients: Efficacy and Microbiological Safety

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: Fundación para la Investigación Biosanitaria del Principado de Asturias · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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

Conditions

• Febrile Neutropenia

Interventions

Type	Name	Description
DRUG	Fosfomycin Calcium	Oral fosfomycin, three times daily, starting from the first day of induction chemotherapy or conditioning until absolute neutrophil count \>0,5x109/L.

Timeline

• Start date: 2022-03-14
• Primary completion: 2024-03-14
• Completion: 2024-03-14
• First posted: 2022-04-05
• Last updated: 2023-09-14

Locations

1 site across 1 country: Spain