Effectiveness and tolerability of intravenous fosfomycin in treating complicated urinary tract infections caused by Escherichia coli: a prospective cohort study from the FOSFOMIC project

Objectives: The FOSFOMIC study assessed the clinical and microbiological effectiveness, and safety of intravenous fosfomycin in treating complicated urinary tract infections (cUTIs) caused by Escherichia coli, in comparison with other intravenous antimicrobials. Methods: A prospective, multinational...

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Autores: Moreno Mellado, Elisa, Aslan, Abdullah Tarik, Akova, Murat, León, Eva, Merchante Gutiérrez, Nicolás, Vinuesa, David, Merino Bohórquez, Vicente, Rodríguez-Baño, Jesús, Docobo Pérez, Fernando, Gutiérrez Gutiérrez, Belén
Tipo de recurso: artículo
Estado:Versión aceptada para publicación
Fecha de publicación:2025
País:España
Institución:Universidad de Sevilla (US)
Repositorio:idUS. Depósito de Investigación de la Universidad de Sevilla
OAI Identifier:oai:dnet:idus________::a33e01145acc0f5b53d2225c98925c63
Acceso en línea:https://hdl.handle.net/11441/175250
https://doi.org/10.1016/j.cmi.2025.01.007
Access Level:acceso abierto
Palabra clave:1. Bacteraemia
Complicated urinary tract infection
Escherichia coli
Intravenous fosfomycin
Pyelonephritis
Safety
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spelling Effectiveness and tolerability of intravenous fosfomycin in treating complicated urinary tract infections caused by Escherichia coli: a prospective cohort study from the FOSFOMIC projectMoreno Mellado, ElisaAslan, Abdullah TarikAkova, MuratLeón, EvaMerchante Gutiérrez, NicolásVinuesa, DavidMerino Bohórquez, VicenteRodríguez-Baño, JesúsDocobo Pérez, FernandoGutiérrez Gutiérrez, Belén1. BacteraemiaComplicated urinary tract infectionEscherichia coliIntravenous fosfomycinPyelonephritisSafetyObjectives: The FOSFOMIC study assessed the clinical and microbiological effectiveness, and safety of intravenous fosfomycin in treating complicated urinary tract infections (cUTIs) caused by Escherichia coli, in comparison with other intravenous antimicrobials. Methods: A prospective, multinational matched cohorts study involving adults with community-acquired cUTIs and receiving targeted therapy with intravenous fosfomycin or other first-line drugs (beta-lactams or fluoroquinolones) was conducted from November 2019 to May 2023 in ten centres from Spain, Italy, and Türkiye. Matching criteria included type of infection acquisition, Charlson and Pitt scores. Endpoints were clinical and microbiological cure, mortality, recurrence, and adverse effects. Analyses used conditional logistic regression and desirability of outcome ranking (DOOR). Results: Overall, 155 matched pairs were included. Clinical and microbiological cure rates were 65.2% (101/155; 95% CI, 57.4–72.2) and 63.2% (98/155; 95% CI, 55.4–70.4) with fosfomycin and comparators, respectively (adjusted OR, 1.09; 95% CI, 0.68–1.73; p 0.73). Mortality rates were 1.9% (3/155; 95% CI, 0.7–5.5) and 5.8% (9/155; 95% CI, 3.1–10.7), respectively (p 0.11). Recurrence rates were 14.2% (22/155; 95% CI, 9.6–20.6) in the fosfomycin group vs. 10.3% (16/155; 95% CI, 6.1–16.1) (p 0.39). Severe adverse effects occurred in 1.9% (3/155; 95% CI, 0.7–5.5) of patients treated with fosfomycin vs. 0.6% (1/155; 95% CI, 0.0–3.3) in the control group (p 0.62). Non-severe adverse effects were more frequent with fosfomycin, affecting 23.3% (36/155; 95% CI, 17.0–30.7) compared with 7.7% (12/155; 95% CI, 4.1–13.1) in the control group (adjusted OR, 5.36; 95% CI, 2.04–14.1; p < 0.001). In DOOR analysis, fosfomycin demonstrated comparable effectiveness in treating pyelonephritis (probability of better DOOR, 54.0%; 95% CI, 48.5–59.6) and in comparison with ceftriaxone (50.3%; 95% CI, 44.7–55.8), without evidence of inferiority in bacteraemic urinary tract infections (DOOR, 47.3%; 95% CI, 41.7–52.8). Discussion: Fosfomycin is a viable option for treating cUTIs caused by E. coli, allowing for diversification in the treatment of these high-incidence infections.ElsevierMedicinaFarmacologíaMicrobiologíaCIBERINFECEuropean Union (UE)Gobierno de EspañaInstituto de Salud Carlos III2025info:eu-repo/semantics/articleinfo:eu-repo/semantics/acceptedVersionapplication/pdfapplication/pdfhttps://hdl.handle.net/11441/175250https://doi.org/10.1016/j.cmi.2025.01.007reponame:idUS. Depósito de Investigación de la Universidad de Sevillainstname:Universidad de Sevilla (US)InglésClinical Microbiology and Infection, 31 (5), 839-846.21/13/0001221/13/00049FIS PI18/01849REIPI RD16/0016/ 0001RD16/0016/0008NT22/00089https://www.clinicalmicrobiologyandinfection.com/article/S1198-743X(25)00012-6/abstractinfo:eu-repo/semantics/openAccessoai:dnet:idus________::a33e01145acc0f5b53d2225c98925c632026-06-17T12:51:07Z
dc.title.none.fl_str_mv Effectiveness and tolerability of intravenous fosfomycin in treating complicated urinary tract infections caused by Escherichia coli: a prospective cohort study from the FOSFOMIC project
title Effectiveness and tolerability of intravenous fosfomycin in treating complicated urinary tract infections caused by Escherichia coli: a prospective cohort study from the FOSFOMIC project
spellingShingle Effectiveness and tolerability of intravenous fosfomycin in treating complicated urinary tract infections caused by Escherichia coli: a prospective cohort study from the FOSFOMIC project
Moreno Mellado, Elisa
1. Bacteraemia
Complicated urinary tract infection
Escherichia coli
Intravenous fosfomycin
Pyelonephritis
Safety
title_short Effectiveness and tolerability of intravenous fosfomycin in treating complicated urinary tract infections caused by Escherichia coli: a prospective cohort study from the FOSFOMIC project
title_full Effectiveness and tolerability of intravenous fosfomycin in treating complicated urinary tract infections caused by Escherichia coli: a prospective cohort study from the FOSFOMIC project
title_fullStr Effectiveness and tolerability of intravenous fosfomycin in treating complicated urinary tract infections caused by Escherichia coli: a prospective cohort study from the FOSFOMIC project
title_full_unstemmed Effectiveness and tolerability of intravenous fosfomycin in treating complicated urinary tract infections caused by Escherichia coli: a prospective cohort study from the FOSFOMIC project
title_sort Effectiveness and tolerability of intravenous fosfomycin in treating complicated urinary tract infections caused by Escherichia coli: a prospective cohort study from the FOSFOMIC project
dc.creator.none.fl_str_mv Moreno Mellado, Elisa
Aslan, Abdullah Tarik
Akova, Murat
León, Eva
Merchante Gutiérrez, Nicolás
Vinuesa, David
Merino Bohórquez, Vicente
Rodríguez-Baño, Jesús
Docobo Pérez, Fernando
Gutiérrez Gutiérrez, Belén
author Moreno Mellado, Elisa
author_facet Moreno Mellado, Elisa
Aslan, Abdullah Tarik
Akova, Murat
León, Eva
Merchante Gutiérrez, Nicolás
Vinuesa, David
Merino Bohórquez, Vicente
Rodríguez-Baño, Jesús
Docobo Pérez, Fernando
Gutiérrez Gutiérrez, Belén
author_role author
author2 Aslan, Abdullah Tarik
Akova, Murat
León, Eva
Merchante Gutiérrez, Nicolás
Vinuesa, David
Merino Bohórquez, Vicente
Rodríguez-Baño, Jesús
Docobo Pérez, Fernando
Gutiérrez Gutiérrez, Belén
author2_role author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Medicina
Farmacología
Microbiología
CIBERINFEC
European Union (UE)
Gobierno de España
Instituto de Salud Carlos III
dc.subject.none.fl_str_mv 1. Bacteraemia
Complicated urinary tract infection
Escherichia coli
Intravenous fosfomycin
Pyelonephritis
Safety
topic 1. Bacteraemia
Complicated urinary tract infection
Escherichia coli
Intravenous fosfomycin
Pyelonephritis
Safety
description Objectives: The FOSFOMIC study assessed the clinical and microbiological effectiveness, and safety of intravenous fosfomycin in treating complicated urinary tract infections (cUTIs) caused by Escherichia coli, in comparison with other intravenous antimicrobials. Methods: A prospective, multinational matched cohorts study involving adults with community-acquired cUTIs and receiving targeted therapy with intravenous fosfomycin or other first-line drugs (beta-lactams or fluoroquinolones) was conducted from November 2019 to May 2023 in ten centres from Spain, Italy, and Türkiye. Matching criteria included type of infection acquisition, Charlson and Pitt scores. Endpoints were clinical and microbiological cure, mortality, recurrence, and adverse effects. Analyses used conditional logistic regression and desirability of outcome ranking (DOOR). Results: Overall, 155 matched pairs were included. Clinical and microbiological cure rates were 65.2% (101/155; 95% CI, 57.4–72.2) and 63.2% (98/155; 95% CI, 55.4–70.4) with fosfomycin and comparators, respectively (adjusted OR, 1.09; 95% CI, 0.68–1.73; p 0.73). Mortality rates were 1.9% (3/155; 95% CI, 0.7–5.5) and 5.8% (9/155; 95% CI, 3.1–10.7), respectively (p 0.11). Recurrence rates were 14.2% (22/155; 95% CI, 9.6–20.6) in the fosfomycin group vs. 10.3% (16/155; 95% CI, 6.1–16.1) (p 0.39). Severe adverse effects occurred in 1.9% (3/155; 95% CI, 0.7–5.5) of patients treated with fosfomycin vs. 0.6% (1/155; 95% CI, 0.0–3.3) in the control group (p 0.62). Non-severe adverse effects were more frequent with fosfomycin, affecting 23.3% (36/155; 95% CI, 17.0–30.7) compared with 7.7% (12/155; 95% CI, 4.1–13.1) in the control group (adjusted OR, 5.36; 95% CI, 2.04–14.1; p < 0.001). In DOOR analysis, fosfomycin demonstrated comparable effectiveness in treating pyelonephritis (probability of better DOOR, 54.0%; 95% CI, 48.5–59.6) and in comparison with ceftriaxone (50.3%; 95% CI, 44.7–55.8), without evidence of inferiority in bacteraemic urinary tract infections (DOOR, 47.3%; 95% CI, 41.7–52.8). Discussion: Fosfomycin is a viable option for treating cUTIs caused by E. coli, allowing for diversification in the treatment of these high-incidence infections.
publishDate 2025
dc.date.none.fl_str_mv 2025
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/acceptedVersion
format article
status_str acceptedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/11441/175250
https://doi.org/10.1016/j.cmi.2025.01.007
url https://hdl.handle.net/11441/175250
https://doi.org/10.1016/j.cmi.2025.01.007
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Clinical Microbiology and Infection, 31 (5), 839-846.
21/13/00012
21/13/00049
FIS PI18/01849
REIPI RD16/0016/ 0001
RD16/0016/0008
NT22/00089
https://www.clinicalmicrobiologyandinfection.com/article/S1198-743X(25)00012-6/abstract
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv reponame:idUS. Depósito de Investigación de la Universidad de Sevilla
instname:Universidad de Sevilla (US)
instname_str Universidad de Sevilla (US)
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