@article{10902/36666,
year = {2025},
url = {https://hdl.handle.net/10902/36666},
abstract = {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.},
organization = {Scren (Spanish Clinical research network, funded by Instituto de Salud Carlos III (PT17/0017/0012 and PT20/00123)).},
publisher = {Elsevier},
publisher = {International Journal of Infectious Diseases: IJID: Official Publication of the International Society for Infectious Diseases, 2025, 156, 107917},
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},
author = {Rando, Emanuele and Delgado-Valverde, Mercedes and Goikoetxea Aguirre, Josune and Guio Carrión, Laura and Blanco Vidal, María José and Barrios Andrés, José Luis and Pérez Rodríguez, María Tersesa and Martínez Lamas, Lucía and Arnaiz de las Revillas Almajano, Francisco and Armiñanzas Castillo, Carlos and Ruiz de Alegría Puig, Carlos and Jiménez Aguilar, Patricia and Martínez-Rubio, María del Carmen and Sáez-Béjarf, Carmen and Cuevas, Carmen de las and Martín-Aspas, Andrés and Galán, Fátima and Yuste, José Ramón and Leiva-León, Lucía and Bou, Germán},
}