“针对重症肺炎的HIV感染婴儿巨细胞病毒和结核的经验性治疗”临床试验的统计分析计划
Statistical analysis plan for the "empirical treatment against cytomegalovirus and tuberculosis in HIV-infected infants with severe pneumonia" clinical trial.
作者信息
Domínguez-Rodríguez Sara, Lora David, Tagarro Alfredo, Moraleda Cinta, Ballesteros Álvaro, Madrid Lola, Manukyan Lilit, Marcy Olivier, Leroy Valeriane, Nardone Alessandra, Burger David, Bassat Quique, Bates Matthew, Moh Raoul, Tam Pui-Ying Iroh, Mvalo Tisungane, Magallhaes Justina, Buck W Chris, Sacarlal Jahit, Mussime Victor, Chabala Chishala, Mujuru Hilda Angela, Rojo Pablo
机构信息
Instituto de Investigación Sanitaria Hospital (imas12), Fundación Biomedica del Hospital Universitario (FIB-H12O), Madrid, Spain.
Universidad Europea, Madrid, Spain.
出版信息
Trials. 2025 Apr 30;26(1):144. doi: 10.1186/s13063-025-08841-7.
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.
背景
“经验性治疗婴幼儿严重肺炎合并感染研究”（EMPIRICAL）试验旨在评估针对巨细胞病毒（CMV）和结核病（TB）的经验性治疗与标准治疗（SoC）相比，对非洲因严重肺炎住院的感染艾滋病毒婴儿不良事件、15天和1年死亡率的安全性和有效性。
方法与设计
“经验性治疗婴幼儿严重肺炎合并感染研究”（EMPIRICAL）试验（NCT03915366）是一项在六个非洲国家进行的国际多中心II-III期开放标签随机析因临床试验。该试验有四个随机分组臂，比例为1:1:1:1，患者被分配到（i）结核病治疗加标准治疗，（ii）缬更昔洛韦加标准治疗，（iii）结核病治疗和缬更昔洛韦加标准治疗，以及（iv）仅标准治疗。
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，该计划需要在数据库锁定和最终分析结果之前发表。统计分析计划包括将进行的分析细节以及为解决主要和次要终点而将报告的空表。数据库将于2025年1月31日锁定。
试验注册
ClinicalTrials.gov：NCT03915366（2019年4月16日注册），通用试验编号：U111-1231-4736，泛非临床试验注册中心：PACTR201994797961340。
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