Effectiveness of oral step-down therapy and early oral switch for bloodstream infections caused by Enterobacterales: A post hoc emulation trial of the SIMPLIFY trial

Objectives We investigated the effectiveness of early oral switch for treating Enterobacterales bloodstream infection (BSI) by performing a post hoc emulation trial of the SIMPLIFY trial. Methods We conducted a post hoc analysis of a randomized controlled trial. We specified the target trial charact...

Descripción completa

Detalles Bibliográficos
Autores: Rando, Emanuele, Delgado Valverde, María Mercedes, Goikoetxea Aguirre, Josune, Guío Carrión, Laura, Blanco Vidal, María José, Barrios Andrés, José Luis, Retamar Gentil, Pilar, Rodríguez-Baño, Jesús, López-Cortés, Luis E.
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2025
País:España
Institución:Universidad de Sevilla (US)
Repositorio:idUS. Depósito de Investigación de la Universidad de Sevilla
OAI Identifier:oai:idus.us.es:11441/175952
Acceso en línea:https://hdl.handle.net/11441/175952
https://doi.org/10.1016/j.ijid.2025.107917
Access Level:acceso abierto
Palabra clave:Antimicrobial stewardship
Oral switch
Enterobacterales
Bloodstream infection
id ES_9b642aa426b3d2e2eb3f61a4ae4259c7
oai_identifier_str oai:idus.us.es:11441/175952
network_acronym_str ES
network_name_str España
repository_id_str
spelling Effectiveness of oral step-down therapy and early oral switch for bloodstream infections caused by Enterobacterales: A post hoc emulation trial of the SIMPLIFY trialRando, EmanueleDelgado Valverde, María MercedesGoikoetxea Aguirre, JosuneGuío Carrión, LauraBlanco Vidal, María JoséBarrios Andrés, José LuisRetamar Gentil, PilarRodríguez-Baño, JesúsLópez-Cortés, Luis E.Antimicrobial stewardshipOral switchEnterobacteralesBloodstream infectionObjectives We investigated the effectiveness of early oral switch for treating Enterobacterales bloodstream infection (BSI) by performing a post hoc emulation trial of the SIMPLIFY trial. Methods We conducted a post hoc analysis of a randomized controlled trial. We specified the target trial characteristics selecting patients who achieved clinical stability on day 5. We categorized patients into those who switched on day 5 and those who continued intravenously. The primary outcome was clinical cure at the test of cure. We set a propensity score for being switched on day 5 to reduce confounding. We ran simple, not-propensity-adjusted, and propensity-adjusted logistic regression models to ascertain the association of switch on day 5 with clinical cure. Results Among 303 patients who achieved clinical stability on day 5, 110 (36.3%) were switched orally on day 5, and 193 (63.7%) were kept intravenously. We detected no difference in clinical cure between those switched on day 5 and those continued intravenously (risk ratios 1.04, 95% confidence intervals [CI] 0.98-1.10). Propensity-adjusted analysis did not show an association between day 5 switch and clinical cure (OR 2.10, 95% CI 0.96-7.41). Conclusion Oral step-down therapy on day 5 was not associated with worse clinical cure for Enterobacterales BSI.Elsevier Science Ltd.MedicinaInstituto de Salud Carlos IIIMinisterio de Ciencia, Innovación y UniversidadesGobierno de España2025info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttps://hdl.handle.net/11441/175952https://doi.org/10.1016/j.ijid.2025.107917reponame:idUS. Depósito de Investigación de la Universidad de Sevillainstname:Universidad de Sevilla (US)InglésInternational Journal of Infectious Diseases, 156, 107917.PT17/0017/0012PT20/00123REIPI RD16/0016/0001; 0002; 0003; 0005; 0007; 0008; 0009; 0011; 0012; 0015https://www.ijidonline.com/article/S1201-9712(25)00140-7/fulltextinfo:eu-repo/semantics/openAccessoai:idus.us.es:11441/1759522026-06-17T12:51:07Z
dc.title.none.fl_str_mv Effectiveness of oral step-down therapy and early oral switch for bloodstream infections caused by Enterobacterales: A post hoc emulation trial of the SIMPLIFY trial
title Effectiveness of oral step-down therapy and early oral switch for bloodstream infections caused by Enterobacterales: A post hoc emulation trial of the SIMPLIFY trial
spellingShingle Effectiveness of oral step-down therapy and early oral switch for bloodstream infections caused by Enterobacterales: A post hoc emulation trial of the SIMPLIFY trial
Rando, Emanuele
Antimicrobial stewardship
Oral switch
Enterobacterales
Bloodstream infection
title_short Effectiveness of oral step-down therapy and early oral switch for bloodstream infections caused by Enterobacterales: A post hoc emulation trial of the SIMPLIFY trial
title_full Effectiveness of oral step-down therapy and early oral switch for bloodstream infections caused by Enterobacterales: A post hoc emulation trial of the SIMPLIFY trial
title_fullStr Effectiveness of oral step-down therapy and early oral switch for bloodstream infections caused by Enterobacterales: A post hoc emulation trial of the SIMPLIFY trial
title_full_unstemmed Effectiveness of oral step-down therapy and early oral switch for bloodstream infections caused by Enterobacterales: A post hoc emulation trial of the SIMPLIFY trial
title_sort Effectiveness of oral step-down therapy and early oral switch for bloodstream infections caused by Enterobacterales: A post hoc emulation trial of the SIMPLIFY trial
dc.creator.none.fl_str_mv Rando, Emanuele
Delgado Valverde, María Mercedes
Goikoetxea Aguirre, Josune
Guío Carrión, Laura
Blanco Vidal, María José
Barrios Andrés, José Luis
Retamar Gentil, Pilar
Rodríguez-Baño, Jesús
López-Cortés, Luis E.
author Rando, Emanuele
author_facet Rando, Emanuele
Delgado Valverde, María Mercedes
Goikoetxea Aguirre, Josune
Guío Carrión, Laura
Blanco Vidal, María José
Barrios Andrés, José Luis
Retamar Gentil, Pilar
Rodríguez-Baño, Jesús
López-Cortés, Luis E.
author_role author
author2 Delgado Valverde, María Mercedes
Goikoetxea Aguirre, Josune
Guío Carrión, Laura
Blanco Vidal, María José
Barrios Andrés, José Luis
Retamar Gentil, Pilar
Rodríguez-Baño, Jesús
López-Cortés, Luis E.
author2_role author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Medicina
Instituto de Salud Carlos III
Ministerio de Ciencia, Innovación y Universidades
Gobierno de España
dc.subject.none.fl_str_mv Antimicrobial stewardship
Oral switch
Enterobacterales
Bloodstream infection
topic Antimicrobial stewardship
Oral switch
Enterobacterales
Bloodstream infection
description Objectives We investigated the effectiveness of early oral switch for treating Enterobacterales bloodstream infection (BSI) by performing a post hoc emulation trial of the SIMPLIFY trial. Methods We conducted a post hoc analysis of a randomized controlled trial. We specified the target trial characteristics selecting patients who achieved clinical stability on day 5. We categorized patients into those who switched on day 5 and those who continued intravenously. The primary outcome was clinical cure at the test of cure. We set a propensity score for being switched on day 5 to reduce confounding. We ran simple, not-propensity-adjusted, and propensity-adjusted logistic regression models to ascertain the association of switch on day 5 with clinical cure. Results Among 303 patients who achieved clinical stability on day 5, 110 (36.3%) were switched orally on day 5, and 193 (63.7%) were kept intravenously. We detected no difference in clinical cure between those switched on day 5 and those continued intravenously (risk ratios 1.04, 95% confidence intervals [CI] 0.98-1.10). Propensity-adjusted analysis did not show an association between day 5 switch and clinical cure (OR 2.10, 95% CI 0.96-7.41). Conclusion Oral step-down therapy on day 5 was not associated with worse clinical cure for Enterobacterales BSI.
publishDate 2025
dc.date.none.fl_str_mv 2025
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/11441/175952
https://doi.org/10.1016/j.ijid.2025.107917
url https://hdl.handle.net/11441/175952
https://doi.org/10.1016/j.ijid.2025.107917
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv International Journal of Infectious Diseases, 156, 107917.
PT17/0017/0012
PT20/00123
REIPI RD16/0016/0001; 0002; 0003; 0005; 0007; 0008; 0009; 0011; 0012; 0015
https://www.ijidonline.com/article/S1201-9712(25)00140-7/fulltext
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 Science Ltd.
publisher.none.fl_str_mv Elsevier Science Ltd.
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)
reponame_str idUS. Depósito de Investigación de la Universidad de Sevilla
collection idUS. Depósito de Investigación de la Universidad de Sevilla
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869414517224505344
score 15,812429