FOVOCIP study: a multicenter randomized trial of fosfomycin versus ciprofloxacin for febrile neutropenia in hematologic patients-efficacy and microbiologic safety

Fecha de publicación: 27/10/2023 Fecha Ahead of Print: 27/10/2023

Autores de IIS La Fe

• Blanca Boluda Pascual

  Autor

Participantes ajenos a IIS La Fe

• Moreno, Ainhoa Fernandez
• Lavin-Alconero, Lucia
• de Ugarriza, Paula Lopez
• Blanco, Laura Solan
• Hernandez, Sara Caceres
• Burgues, Juan Miguel Bergua
• de Miguel, Maria Izquierdo
• Huerta, Ana Julia Gonzalez
• Zarzuela, Marta Polo
• Humala, Karem
• Calabuig, Maria Luisa
• Amigo, Maria Luz
• Casas, Marian Cuesta
• Garcia-Saiz, Maria del Mar
• Verdugo, Ana Fernandez
• Dominguez, Javier Fernandez
• Bernal, Teresa

Grupos

• Hematología y Hemoterapia

  

  Investigador Principal

  Javier De La Rubia Comos

Abstract

BackgroundMultidrug-resistant Gram-negative bacterial (MRGNB) infections represent a major public health threat. Cancer patients and, among them, hematological patients are most vulnerable to these infections. Gut colonization by MRGNB is a common phenomenon occurring during hospitalization and chemotherapy exposure. In the neutropenic phase that occurs after chemotherapy, MRGNB translocation occurs increasing patient's mortality. Fluoroquinolone prophylaxis with ciprofloxacin or levofloxacin efficacy is now being questioned due to the increase of incidence in MRGNB.MethodsA phase III randomized, controlled, clinical trial, open-label parallel-group with a 1:1 ratio, aimed to demonstrate the non-inferiority of oral fosfomycin versus oral ciprofloxacin for febrile neutropenia prevention in patients with acute leukemia (AL) or hematopoietic cell transplant (HSC) receptors. Weekly surveillance cultures are planned to detect gut colonization. Changes in fecal microbiome at the beginning and end of prophylaxis will also be analyzed.DiscussionThis trial will provide evidence of the efficacy of an alternative drug to ciprofloxacin for febrile neutropenia prevention in high-risk hematological patients. The battery of planned microbiological studies will allow us to evaluate prospectively the microbiological safety of both pharmacological strategies in terms of the selection of MRGNB occurring in each arm. In addition, valuable information on the way in which each drug changes the fecal microbiome of the patients throughout the treatment will be generated.Trial registrationClinical trials NCT05311254, Registered on 5 April 2022, https://clinicaltrials.gov/ct2/show/NCT05311254?term=FOVOCIP&cntry=ES&dr aw=2&rank=1. Protocol version: 3.0, dated 20 May 2022.

© 2023. The Author(s).

Keywords

• Hematological neoplasms; Febrile neutropenia; Prophylaxis; Gram-negative resistant bacteria; Randomized controlled trial