08Feb 2023
High dose rifampin for 2 months vs standard dose rifampin for 4 months, to treat TB infection: Protocol of a 3-arm randomized trial (2R2)

High dose rifampin for 2 months vs standard dose rifampin for 4 months, to treat TB infection: Protocol of a 3-arm randomized trial (2R2)

The objective of this trial is to test the safety of high-dose rifampin monotherapy to shorten the duration of the currently recommended TPT of 4 months of rifampin. This is a phase 2b, randomised, controlled, parallel-group, superiority, partially-blind trial. Primary outcomes are completion of treatment (as a proxy measure of tolerability) and safety. Completion is the primary outcome, measured by pill count and is defined as taking a minimum of 80% of treatment in 120% of the allowed time; it will be tested for superiority by logistic regression. Safety outcome comprises proportion of grade 3-5 adverse events and grade 1-2 rash, adjudicated related to study drug, and resulting in permanent drug discontinuation; compared for non-inferiority between each of the two high dose arms and the standard arm, using Poisson regression. A sample size of 1,359 participants will give 80% power to detect a 10% difference in completion rates and a 1% difference in the safety outcome.

  • #family health

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