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

IF 4.8 2区医学 Q1 INFECTIOUS DISEASES

International Journal of Infectious Diseases Pub Date : 2025-04-29 DOI:10.1016/j.ijid.2025.107917

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 , Luis Eduardo López Cortés

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引用次数: 0

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.

查看原文本刊更多论文

口服降压治疗和早期口服转换对肠杆菌引起的血流感染的有效性：一项对SIMPLIFY试验的事后模拟试验

目的通过简化试验的事后模拟试验，研究早期口服开关治疗肠杆菌血液感染（BSI）的有效性。方法对一项随机对照试验进行事后分析。我们指定了目标试验特征，选择在第5天达到临床稳定的患者。我们将患者分为第5天切换的患者和继续静脉注射的患者。主要结果为临床治愈。我们设置了在第5天切换的倾向评分，以减少混淆。我们运行简单的、非倾向调整的和倾向调整的逻辑回归模型来确定第5天开关与临床治愈的关系。结果在第5天临床稳定的303例患者中，第5天转口服110例（36.3%），静脉留用193例（63.7%）。我们发现在第5天切换的患者和继续静脉注射的患者在临床治愈率上没有差异（风险比1.04,95%可信区间[CI] 0.98-1.10）。倾向校正分析未显示第5天切换与临床治愈之间的关联（OR 2.10, 95% CI 0.96-7.41）。结论口服降压治疗第5天与肠杆菌BSI临床治愈率不相关。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

International Journal of Infectious Diseases 医学-传染病学

CiteScore

18.90

自引率

2.40%

发文量

1020

审稿时长

30 days

期刊介绍： International Journal of Infectious Diseases (IJID) Publisher: International Society for Infectious Diseases Publication Frequency: Monthly Type: Peer-reviewed, Open Access Scope: Publishes original clinical and laboratory-based research. Reports clinical trials, reviews, and some case reports. Focuses on epidemiology, clinical diagnosis, treatment, and control of infectious diseases. Emphasizes diseases common in under-resourced countries.