Empirical tuberculosis treatment in infants living with HIV hospitalised with severe pneumonia in Africa (EMPIRICAL): a multicentre, randomised, open-label, 2 × 2 factorial, controlled superiority trial.

Empirical tuberculosis treatment added to standard care did not reduce all-cause mortality versus a clinically and microbiologically guided strategy in 558 infants with severe HIV-associated pneumonia.

• Why it matters: Mortality in infants with severe HIV-associated pneumonia remains high, and it is unclear whether empiric tuberculosis therapy improves survival beyond current diagnostic-guided practice.
• What they did: In 19 African hospitals, 28–365-day-old infants were randomized 1:1:1:1 to standard care with or without 6 months of tuberculosis treatment, with or without 15 days of oral valganciclovir; mortality at 15 and 360 days was analyzed with flexible parametric models.
• The result: At 12 months, 48% (132/276) in the empirical tuberculosis groups died versus 43% (121/282) in non-empirical groups (adjusted hazard ratio 1·12, 95% CI 0·87–1·43; p=0·3868), with no evidence of valganciclovir–tuberculosis interaction.

AI summary of the abstract · may contain errors · not medical advice · read the paper.