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

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

Abstract Background Multidrug-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 hospitalizatio...

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Published in:Current controlled trials in cardiovascular medicine Vol. 24; no. 1; p. 694
Main Authors: Moreno, Ainhoa Fernández, Lavín-Alconero, Lucía, de Ugarriza, Paula López, Blanco, Laura Solán, Hernández, Sara Cáceres, Burgués, Juan Miguel Bergua, de Miguel, María Izquierdo, Huerta, Ana Julia González, Zarzuela, Marta Polo, Boluda, Blanca, Humala, Karem, Calabuig, Maria Luisa, Amigo, Maria Luz, Casas, Marián Cuesta, del Mar García-Saiz, María, Verdugo, Ana Fernández, Domínguez, Javier Fernández, Bernal, Teresa
Format: Journal Article
Language:English
Published: London BioMed Central Ltd 27-10-2023
BioMed Central
BMC
Subjects:
Antibiotics
Blood cancer
Cancer
Care and treatment
Chemotherapy
Ciprofloxacin
Clinical trials
Diagnosis
Disease prevention
Febrile neutropenia
Fosfomycin
Gram-negative resistant bacteria
Hematological neoplasms
Hematology
Hematopoietic stem cells
Hospitals
Infections
Leukemia
Medical research
Microbiota
Microorganisms
Neutropenia
Patient outcomes
Prophylaxis
Randomized controlled trial
Stem cell transplantation
Study Protocol
Surveillance
Testing
Transplantation
Tumors
Spain
Madrid Spain
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Summary:Abstract Background Multidrug-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. Methods A 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. Discussion This 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 registration Clinical trials NCT05311254, Registered on 5 April 2022, https://clinicaltrials.gov/ct2/show/NCT05311254?term=FOVOCIP&cntry=ES&draw=2&rank=1 . Protocol version: 3.0, dated 20 May 2022.
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ISSN:1745-6215
1745-6215
DOI:10.1186/s13063-023-07702-5