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The problem
Intervention: 4-month course of rifampin as an alternative to 9-month isoniazid treatment for latent Mycobacterium tuberculosis infection
Who it was tested with: 844 children under 18 years old with latent M. tuberculosis infection, enrolled across multiple countries (Canada, Guinea, Benin, Indonesia, Brazil, Ghana, Australia, New Zealand).
Children or communities are compared with a group that did not receive the intervention, or followed over years. This is the design that best separates what the intervention did from everything else that changed.
"In this multicenter, open-label trial, we randomly assigned 844 children (<18 years of age) with latent M. tuberculosis infection to receive either 4 months of rifampin or 9 months of isoniazid. The primary outcome was adverse events of grade 1 to 5 that resulted in the permanent discontinuation of a trial drug. Secondary outcomes were treatment adherence, side-effect profile, and efficacy. Independent review panels whose members were unaware of trial-group assignments adjudicated all adverse events and progression to active tuberculosis." This design allows causal comparison of the two treatments for safety and effectiveness in preventing tuberculosis disease progression in children.
Open-label design means participants and staff were aware of treatment assignment, potentially influencing adherence reporting and side-effect documentation. The confidence interval for the active tuberculosis rate difference includes zero, suggesting results are not statistically significant for this outcome. Longer-term follow-up data beyond the study period are not available.
Across countries and designs
1 study · 8 countries
