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  3. Fosfomycin versus ciprofloxacin for febrile neutropenia prophylaxis in high-risk haematological patients (FOVOCIP): a phase 3, open-label, multicentre, randomised, non-inferiority trial

Fosfomycin versus ciprofloxacin for febrile neutropenia prophylaxis in high-risk haematological patients (FOVOCIP): a phase 3, open-label, multicentre, randomised, non-inferiority trial

Fecha de publicación:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Moreno A.F.
  • López de Ugarriza P.
  • González Huerta A.J.
  • Cáceres S.
  • Blanco L.S.
  • Calabuig M.L.
  • Zarzuela M.P.
  • Fernández Verdugo A.M.
  • González-Barbera E.M.
  • Izquierdo M.
  • Medel-Plaza M.
  • Colomina J.
  • Olave M.T.
  • Humala K.
  • López L.
  • Labrador J.
  • Seral C.
  • Amigo M.L.
  • de Toro M.
  • Carrascoso G.R.
  • Megías G.
  • Blázquez R.
  • Antuña M.
  • Lumbreras P.
  • Domínguez J.F.
  • Bernal T.

Grupos

Abstract

Background: Prophylaxis with fluoroquinolones in high-risk neutropenic patients is currently under scrutiny. The FOVOCIP study aimed to evaluate the efficacy and safety of fosfomycin compared to ciprofloxacin in this population. Methods: This was a multicentre, randomised, phase-3, non-inferiority, open-label trial performed in 11 centres in Spain. Adults diagnosed with acute leukaemia or recipients of a Haematopoietic Stem Cell Transplant were randomised to receive oral fosfomycin or oral ciprofloxacin as prophylaxis. The primary endpoint was rate of febrile neutropenia. Intention-To-Treat (ITT) and Per-Protocol (PP) analyses were done for the primary endpoint, with a non-inferiority margin of -5%. Findings: A total of 174 patients were screened and 166 randomized (83 per arm, 50% female). In the ITT population, febrile neutropenia occurred in 74.7% (62 of 83 patients) and 73.49% (61 of 83 patients) in the fosfomycin and ciprofloxacin group, respectively. The corresponding success rates (patients without febrile neutropenia) were 25.3% in the fosfomycin group and 26.51% int the ciprofloxacin group, risk difference -1.2%, (95% confidence interval [CI]: -14.5 to 12.12, lower boundary of the 90% CI -12.3). In the PP population, febrile neutropenia occurred in 82.19% (60 of 73 patients) and 76.25% (61 of 80 patients) in the fosfomycin and ciprofloxacin group respectively. The corresponding success rates were 17.81% in the fosfomycin group and 23.75% in the ciprofloxacin group, risk difference -5.94%, (95% CI: -18.75 to 6.86, lower boundary of the 90% CI -16.7). Gram negative bacteria were responsible for 90% and 10% of the bacteraemias in the fosfomycin and ciprofloxacin group, respectively. Two patients (3%) in the experimental group became colonized by multidrug resistant Gram-negative bacteria, compared with nine patients (11%) in the control group (P = 0.04). There were no differences in other safety endpoints. Interpretation: Fosfomycin did not demonstrate non-inferiority to ciprofloxacin in the prevention of febrile neutropenia in high-risk haematological patients. The higher incidence of Gram-negative bacteraemia also discourages its use. This trial is registered with ClinicalTrials.gov (NCT05311254) and EUDRACT (2021-000354-25) and is complete. Funding: Instituto de Salud Carlos III (PI21/1590 AES 2021, co-funded by European Union), Agencia SEKUENS (IDE/2024/000797), Instituto de Investigación del Principado de Asturias (ITM25-INT). © 2026 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license. http://creativecommons.org/licenses/by-nc-nd/4.0/

Datos de la publicación

ISSN/ISSNe:
2666-7762, 2666-7762

Lancet Regional Health-Europe  ELSEVIER

Tipo:
Article
Páginas:
-
PubMed:
42164340
Enlace a otro recurso:
www.scopus.com

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Keywords

  • Clinical trial; Febrile neutropenia; Prophylaxis

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