Statistical analysis plan for the "empirical treatment against cytomegalovirus and tuberculosis in HIV-infected infants with severe pneumonia" clinical trial.

IF 2 4区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Trials Pub Date : 2025-04-30 DOI:10.1186/s13063-025-08841-7

Sara Domínguez-Rodríguez, David Lora, Alfredo Tagarro, Cinta Moraleda, Álvaro Ballesteros, Lola Madrid, Lilit Manukyan, Olivier Marcy, Valeriane Leroy, Alessandra Nardone, David Burger, Quique Bassat, Matthew Bates, Raoul Moh, Pui-Ying Iroh Tam, Tisungane Mvalo, Justina Magallhaes, W Chris Buck, Jahit Sacarlal, Victor Mussime, Chishala Chabala, Hilda Angela Mujuru, Pablo Rojo

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引用次数: 0

Abstract

Background: The EMPIRICAL trial aims to assess safety and efficacy of an empirical treatment against cytomegalovirus (CMV) and tuberculosis (TB) compared to standard of care (SoC), on adverse events and 15-day and 1-year mortality among infants living with HIV hospitalized with severe pneumonia in Africa.

Methods and design: The EMPIRICAL trial (NCT03915366) is an international multicenter phase II-III, open-label randomized factorial clinical trial conducted in six African countries. The trial has four randomization arms in a 1:1:1:1 fashion with patients allocated to (i) TB-Treatment plus SoC, (ii) valganciclovir plus SoC, (iii) both TB-Treatment and valganciclovir plus SoC, and (iv) SoC only.

Discussion: This paper describes the statistical analysis plan (SAP) for the trial which, per the study publication plan, needs to be published prior to the database lock and final analysis results. The SAP includes details of the analyses to be undertaken and unpopulated tables that will be reported to address primary and secondary endpoints. The database will be locked on 31st January 2025.

Trial registration: ClinicalTrials.gov: NCT03915366 (registered on April 16, 2019), Universal Trial Number: U111-1231-4736, Pan African Clinical Trial Registry: PACTR201994797961340.

查看原文本刊更多论文

“实验性治疗巨细胞病毒和结核治疗hiv感染婴儿重症肺炎”临床试验的统计分析方案。

背景：该经验性试验旨在评估与标准护理（SoC）相比，针对巨细胞病毒（CMV）和结核病（TB）的经验性治疗的安全性和有效性，以及非洲因严重肺炎住院的艾滋病毒感染婴儿的不良事件和15天和1年死亡率。方法与设计：经验性试验（NCT03915366）是一项国际多中心II-III期、开放标签随机因子临床试验，在6个非洲国家进行。该试验有四个随机分组，按1:1:1:1的比例将患者分配到(i)结核治疗加SoC，（ii）缬更昔洛韦加SoC，（iii）结核治疗和缬更昔洛韦加SoC，以及（iv）仅SoC。讨论：本文描述了该试验的统计分析计划（SAP），根据研究发表计划，该试验需要在数据库锁定和最终分析结果之前发表。SAP包括要进行的分析的细节和将报告的未填充表，以处理主要和次要端点。该数据库将于2025年1月31日锁定。试验注册：ClinicalTrials.gov: NCT03915366（注册于2019年4月16日），通用试验编号：U111-1231-4736，泛非临床试验注册：PACTR201994797961340。

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

Trials 医学-医学：研究与实验

CiteScore

3.80

自引率

4.00%

发文量

966

审稿时长

6 months

期刊介绍： Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.