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...
| Autores: | , , , , , , , , |
|---|---|
| Tipo de recurso: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2025 |
| País: | España |
| Institución: | Universidad de Sevilla (US) |
| Repositorio: | idUS. Depósito de Investigación de la Universidad de Sevilla |
| OAI Identifier: | oai:idus.us.es:11441/175952 |
| Acceso en línea: | https://hdl.handle.net/11441/175952 https://doi.org/10.1016/j.ijid.2025.107917 |
| Access Level: | acceso abierto |
| Palabra clave: | Antimicrobial stewardship Oral switch Enterobacterales Bloodstream infection |
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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, EmanueleDelgado Valverde, María MercedesGoikoetxea Aguirre, JosuneGuío Carrión, LauraBlanco Vidal, María JoséBarrios Andrés, José LuisRetamar Gentil, PilarRodríguez-Baño, JesúsLópez-Cortés, Luis E.Antimicrobial 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.Elsevier Science Ltd.MedicinaInstituto de Salud Carlos IIIMinisterio de Ciencia, Innovación y UniversidadesGobierno de España2025info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttps://hdl.handle.net/11441/175952https://doi.org/10.1016/j.ijid.2025.107917reponame:idUS. Depósito de Investigación de la Universidad de Sevillainstname:Universidad de Sevilla (US)InglésInternational Journal of Infectious Diseases, 156, 107917.PT17/0017/0012PT20/00123REIPI RD16/0016/0001; 0002; 0003; 0005; 0007; 0008; 0009; 0011; 0012; 0015https://www.ijidonline.com/article/S1201-9712(25)00140-7/fulltextinfo:eu-repo/semantics/openAccessoai:idus.us.es:11441/1759522026-06-17T12:51:07Z |
| 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, Emanuele 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, 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. |
| author |
Rando, Emanuele |
| author_facet |
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. |
| author_role |
author |
| author2 |
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. |
| author2_role |
author author author author author author author author |
| dc.contributor.none.fl_str_mv |
Medicina Instituto de Salud Carlos III Ministerio de Ciencia, Innovación y Universidades Gobierno de España |
| 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. |
| 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://hdl.handle.net/11441/175952 https://doi.org/10.1016/j.ijid.2025.107917 |
| url |
https://hdl.handle.net/11441/175952 https://doi.org/10.1016/j.ijid.2025.107917 |
| dc.language.none.fl_str_mv |
Inglés |
| language_invalid_str_mv |
Inglés |
| dc.relation.none.fl_str_mv |
International Journal of Infectious Diseases, 156, 107917. PT17/0017/0012 PT20/00123 REIPI RD16/0016/0001; 0002; 0003; 0005; 0007; 0008; 0009; 0011; 0012; 0015 https://www.ijidonline.com/article/S1201-9712(25)00140-7/fulltext |
| dc.rights.none.fl_str_mv |
info:eu-repo/semantics/openAccess |
| eu_rights_str_mv |
openAccess |
| dc.format.none.fl_str_mv |
application/pdf application/pdf |
| dc.publisher.none.fl_str_mv |
Elsevier Science Ltd. |
| publisher.none.fl_str_mv |
Elsevier Science Ltd. |
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reponame:idUS. Depósito de Investigación de la Universidad de Sevilla instname:Universidad de Sevilla (US) |
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Universidad de Sevilla (US) |
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idUS. Depósito de Investigación de la Universidad de Sevilla |
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idUS. Depósito de Investigación de la Universidad de Sevilla |
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