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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Autores: Rando, E, Delgado-Valverde, M, Aguirre, JG, Carrión, LG, Vidal, MJB, Andrés, JLB, Rodríguez, MTP, Lamas, LM, de las Revillas, FA, Armiñanzas, C, de Alegría-Puig, CR, Aguilar, PJ, Martínez-Rubio, MD, 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, MA, 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
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2025
País:España
Institución:Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL)
Repositorio:r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante
OAI Identifier:oai:dnet:isabial_____::4c7088a78195d1f377dd78527fb44669
Acceso en línea:https://isabial.portalinvestigacion.com/publicaciones12528
https://www.sciencedirect.com/science/article/pii/S1201971225001407?pes=vor&utm_source=clarivate&getft_integrator=clarivate
Access Level:acceso abierto
Palabra clave:Antimicrobial stewardship
Oral switch
Enterobacterales
Bloodstream infection
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oai_identifier_str oai:dnet:isabial_____::4c7088a78195d1f377dd78527fb44669
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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, EDelgado-Valverde, MAguirre, JGCarrión, LGVidal, MJBAndrés, JLBRodríguez, MTPLamas, LMde las Revillas, FAArmiñanzas, Cde Alegría-Puig, CRAguilar, PJMartínez-Rubio, MDSáez-Béjar, Cde las Cuevas, CMartín-Aspas, AGalán, FYuste, JRLeiva-León, JBou, GGonzález, PCBoix-Palop, LXercavins-Valls, MGoenaga-Sánchez, MAAnza, DVCastón, JJRufián, MRMerino, ERodríguez, JCLoeches, BRosso-Fernández, CBravo-Ferrer, JMRetamar-Gentil, PRodríguez-Baño, JCortés, LELAntimicrobial 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. (c) 2025 The Author(s). Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)ELSEVIER SCI LTD2025info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://isabial.portalinvestigacion.com/publicaciones12528https://www.sciencedirect.com/science/article/pii/S1201971225001407?pes=vor&utm_source=clarivate&getft_integrator=clarivateINTERNATIONAL JOURNAL OF INFECTIOUS DISEASESISSN: 12019712ISSNe: 18783511reponame:r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicanteinstname:Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL)Inglésinfo:eu-repo/semantics/openAccessoai:dnet:isabial_____::4c7088a78195d1f377dd78527fb446692026-06-12T10:20:37Z
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, E
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, E
Delgado-Valverde, M
Aguirre, JG
Carrión, LG
Vidal, MJB
Andrés, JLB
Rodríguez, MTP
Lamas, LM
de las Revillas, FA
Armiñanzas, C
de Alegría-Puig, CR
Aguilar, PJ
Martínez-Rubio, MD
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, MA
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
author Rando, E
author_facet Rando, E
Delgado-Valverde, M
Aguirre, JG
Carrión, LG
Vidal, MJB
Andrés, JLB
Rodríguez, MTP
Lamas, LM
de las Revillas, FA
Armiñanzas, C
de Alegría-Puig, CR
Aguilar, PJ
Martínez-Rubio, MD
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, MA
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
author_role author
author2 Delgado-Valverde, M
Aguirre, JG
Carrión, LG
Vidal, MJB
Andrés, JLB
Rodríguez, MTP
Lamas, LM
de las Revillas, FA
Armiñanzas, C
de Alegría-Puig, CR
Aguilar, PJ
Martínez-Rubio, MD
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, MA
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
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
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. (c) 2025 The Author(s). Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)
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://isabial.portalinvestigacion.com/publicaciones12528
https://www.sciencedirect.com/science/article/pii/S1201971225001407?pes=vor&utm_source=clarivate&getft_integrator=clarivate
url https://isabial.portalinvestigacion.com/publicaciones12528
https://www.sciencedirect.com/science/article/pii/S1201971225001407?pes=vor&utm_source=clarivate&getft_integrator=clarivate
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv ELSEVIER SCI LTD
publisher.none.fl_str_mv ELSEVIER SCI LTD
dc.source.none.fl_str_mv INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES
ISSN: 12019712
ISSNe: 18783511
reponame:r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante
instname:Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL)
instname_str Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL)
reponame_str r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante
collection r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15.812429

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