drugset / Trial / NCT05311254
A Trial of Fosfomycin vs Ciprofloxacin for Febrile Neutropenia
Phase 3
Unknown
156 enrolled
Fundación para la Investigación Biosanitaria del Principado de Asturias
Instituto de Investigación Marqués de Valdecilla · collabInstituto de Salud Carlos III · collab
RandomizedParallel-groupOpen-labelPrevention
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.
Timeline
- Start
- 2022-03-14
- Primary completion
- 2024-03-14
- Completion
- 2024-03-14
Outcome
Missed primary endpoint
paper Fosfomycin did not demonstrate non-inferiority to ciprofloxacin in the prevention of febrile neutropenia in high-risk haematological patients. PMID 42164340 ↗
paper risk difference -1.2%, (95% confidence interval [CI]: -14.5 to 12.12, lower boundary of the 90% CI -12.3). PMID 42164340 ↗
Publications
- Moreno AF, Lopez de Ugarriza P, Gonzalez Huerta AJ, Pascual BB, Caceres S, Blanco LS, Calabuig ML, Zarzuela MP, Rodriguez-Veiga R, Montesinos P, Fernandez Verdugo AM, Gonzalez-Barbera EM, Izquierdo M, Medel-Plaza M, Colomina J, Olave MT, Humala K, Lopez L, Labrador J, Seral C, Amigo ML, de Toro M, Carrascoso GR, Megias G, Blazquez R, Antuna M, Lumbreras P, Dominguez JF, Bernal T. Fosfomycin versus ciprofloxacin for febrile neutropenia prophylaxis in high-risk haematological patients (FOVOCIP): a phase 3, open-label, multicentre, randomised, non-inferiority trial. Lancet Reg Health Eur. 2026 May 7;66:101698. doi: 10.1016/j.lanepe.2026.101698. eCollection 2026 Jul.
- Moreno AF, Lavin-Alconero L, de Ugarriza PL, Blanco LS, Hernandez SC, Burgues JMB, de Miguel MI, Huerta AJG, Zarzuela MP, Boluda B, Humala K, Calabuig ML, Amigo ML, Casas MC, Del Mar Garcia-Saiz M, Verdugo AF, Dominguez JF, Bernal T. FOVOCIP study: a multicenter randomized trial of fosfomycin versus ciprofloxacin for febrile neutropenia in hematologic patients-efficacy and microbiologic safety. Trials. 2023 Oct 27;24(1):694. doi: 10.1186/s13063-023-07702-5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fosfomycin | Small molecule | 500 mg | Oral |