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

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 chara...

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Main Authors: Emanuele Rando, Mercedes Delgado-Valverde, Josune Goikoetxea Aguirre, Laura Guio Carrión, María José Blanco Vidal, José Luis Barrios Andrés, María Teresa Pérez Rodríguez, Lucía Martínez Lamas, Francisco Arnaiz de las Revillas, Carlos Armiñanzas, Carlos Ruiz de Alegría-Puig, Patricia Jiménez Aguilar, María del Carmen Martínez-Rubio, Carmen Sáez-Béjar, Carmen de las Cuevas, Andrés Martín-Aspas, Fátima Galán, José Ramón Yuste, José Leiva-León, Germán Bou, Patricia Capón González, Lucía Boix-Palop, Mariona Xercavins-Valls, Miguel Ángel Goenaga-Sánchez, Diego Vicente Anza, Juan José Castón, Manuel Recio Rufián, Esperanza Merino, Juan Carlos Rodríguez, Belén Loeches, Clara Rosso-Fernández, José María Bravo-Ferrer, Pilar Retamar-Gentil, Jesús Rodríguez-Baño, Luis Eduardo López Cortés
Format: Article
Language:English
Published: Elsevier 2025-07-01
Series:International Journal of Infectious Diseases
Subjects:
Antimicrobial stewardship
Oral switch
Enterobacterales
Bloodstream infection
Online Access:http://www.sciencedirect.com/science/article/pii/S1201971225001407
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Summary: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.
ISSN:1201-9712

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