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

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

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 pneumo...

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Main Authors: 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, on behalf of EMPIRICAL group
Format: Article
Language:English
Published: BMC 2025-04-01
Series:Trials
Subjects:
Statistical analysis plan
Child mortality
Cytomegalovirus
Empirical
Factorial
Factorial randomized clinical trial
Online Access:https://doi.org/10.1186/s13063-025-08841-7
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