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...

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Detalhes 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 documento: artigo
Estado:Versão publicada
Data de publicação:2025
País:España
Recursos:Universidad de Sevilla (US)
Repositório:idUS. Depósito de Investigación de la Universidad de Sevilla
OAI Identifier:oai:idus.us.es:11441/175952
Acesso em linha:https://hdl.handle.net/11441/175952
https://doi.org/10.1016/j.ijid.2025.107917
Access Level:Acceso aberto
Palavra-chave:Antimicrobial stewardship
Oral switch
Enterobacterales
Bloodstream infection
Descrição
Resumo: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.