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Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05311254
Study type Interventional
Source Fundación para la Investigación Biosanitaria del Principado de Asturias
Contact Teresa Bernal, MD PHD
Phone +34 985108000
Email bernalmaria@uniovi.es
Status Recruiting
Phase Phase 3
Start date March 14, 2022
Completion date March 14, 2024

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