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http://hdl.handle.net/2183/42141 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
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Rando, Emanuele
Delgado-Valverde, Mercedes
Goikoetxea Aguirre, Josune
Guio Carrión, Laura
Blanco Vidal, María José
Barrios Andrés, José Luis
Pérez Rodríguez, María Teresa
Martínez Lamas, Lucía
Arnaiz de las Revillas, Francisco
Armiñanzas, Carlos
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Rando E, Delgado-Valverde M, Aguirre JG, Carrión LG, Vidal MJB, Andrés JLB, Rodríguez MTP, Lamas LM, Arnaiz de Las Revillas F, Armiñanzas C, de Alegría-Puig CR, Aguilar PJ, Martínez-Rubio MDC, Sáez-Béjar C, de Las Cuevas C, Martín-Aspas A, Galán F, Yuste JR, Leiva-León J, Bou G, González PC, Boix-Palop L, Xercavins-Valls M, Goenaga-Sánchez MÁ, Anza DV, Castón JJ, Rufián MR, Merino E, Rodríguez JC, Loeches B, Rosso-Fernández C, Bravo-Ferrer JM, Retamar-Gentil P, Rodríguez-Baño J, Cortés LEL; SIMPLIFY Study Group. 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. Int J Infect Dis. 2025 Apr 29;156:107917
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Abstract
[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.
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