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

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, Iroh Tam, Pui-Ying ORCID: https://orcid.org/0000-0002-3682-8892, Mvalo, Tisungane, Magallhaes, Justina, Buck, W. Chris, Sacarlal, Jahit, Mussime, Victor, Chabala, Chishala, Mujuru, Hilda Angela and Rojo, Pablo (2025) 'Statistical analysis plan for the “empirical treatment against cytomegalovirus and tuberculosis in HIV-infected infants with severe pneumonia” clinical trial'. Trials, Vol 26, Issue 1, p. 144.

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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.

Item Type:	Article
Subjects:	WC Communicable Diseases > Infection. Bacterial Infections > Bacterial Infections > WC 202 Pneumonia (General or not elsewhere classified) WC Communicable Diseases > Virus Diseases > Acquired Immunodeficiency Syndrome. HIV Infections > WC 503 Acquired immunodeficiency syndrome. HIV infections WF Respiratory System > Tuberculosis > WF 200 Tuberculosis (General)
Faculty: Department:	Education
Digital Object Identifer (DOI):	https://doi.org/10.1186/s13063-025-08841-7
SWORD Depositor:	JISC Pubrouter
Depositing User:	JISC Pubrouter
Date Deposited:	15 May 2025 12:49
Last Modified:	15 May 2025 12:49
URI:	https://archive.lstmed.ac.uk/id/eprint/26658

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