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

作     者：Dominguez-Rodriguez, Sara Lora, David Tagarro, Alfredo Moraleda, Cinta Ballesteros, Alvaro 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 

作者机构：Fdn Biomed Hosp Univ FIB H12O Inst Invest Sanitaria Hosp Imas12 Madrid Spain Univ Europea Madrid Spain Spanish Clin Res Network SCReN Madrid Spain Univ Complutense Madrid UCM Fac Estudios Estadisticos Madrid Spain Hosp Univ Infanta Sofia Serv Pediat Serv Madrileno Salud SERMAS Madrid Spain Hosp Univ Serv Pediat Serv Madrileno Salud SERMAS Madrid Spain Sch Hyg & Trop Med Dept Infect Dis Epidemiol London England Univ Bordeaux Bordeaux Populat Hlth GHiGS InsermU1219 Bordeaux France Univ Toulouse 3 Inst Natl Sante & Rech Med Inserm CERPOP Toulouse France Penta Onlus Fdn PENTA Padua Italy Stichting Katholieke Univ Radboudumc RUMC Nijmegen Netherlands Univ Barcelona Hosp Clin ISGlobal Barcelona Spain Univ Barcelona Hosp St Joan Deu Pediat Dept Barcelona Spain ICREA Pg Lluis Co 23 Barcelona 08010 Spain Ctr Invest Saude Manhica CISM Maputo Mozambique Inst Salud Carlos III Consorcio Invest Biomed Red Epidemiol & Salud Publ Madrid Spain Univ Lincoln Lincoln England UFR Sci Med Programme PAC CI Unite Pedag Dermatol & Infectiol Abidjan Cote Ivoire Kamuzu Univ Hlth Sci Blantyre Malawi Liverpool Sch Trop Med LSTM Malawi Liverpool Wellcome Programme MLW Blantyre Malawi UNC Project Malawi Lilongwe Med Relief Trust LMRFT Lilongwe Malawi Univ Calif Los Angeles David Geffen Sch Med Los Angeles CA USA Univ Eduardo Mondlane UEM Maputo Mozambique Makerere Univ Coll Hlth Sci Dept Paediat & Child Hlth Kampala Uganda Joint Clin Res Ctr Kampala Uganda Univ Zambia Sch Med Lusaka Zambia Univ Zimbabwe Harare Zimbabwe Univ Complutense Fac Med Madrid Spain 

出 版 物：《TRIALS》 (Trials)

年 卷 期：2025年第26卷第1期

页      面：1-13页

核心收录：

学科分类：1002[医学-临床医学] 1001[医学-基础医学(可授医学、理学学位)] 100201[医学-内科学(含：心血管病、血液病、呼吸系病、消化系病、内分泌与代谢病、肾病、风湿病、传染病)] 10[医学] 

基　　金：EDCTP [RIA2017MC- 2013] 

主　　题：Statistical analysis plan Child mortality Cytomegalovirus Empirical Factorial Factorial randomized clinical trial HIV Infants Pneumonia Tuberculosis Valganciclovir 

摘      要：BackgroundThe 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 *** and designThe 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 *** 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 *** ***: NCT03915366 (registered on April 16, 2019), Universal Trial Number: U111-1231-4736, Pan African Clinical Trial Registry: PACTR201994797961340.