Innovating shorter, all-oral, precise, individualized treatment regimen for rifampicin-resistant tuberculosis (INSPIRE TB): study protocol for a pragmatic randomised controlled trial
Abstract
Background: Rifampicin-resistant tuberculosis (RR-TB) poses a great threat to global health. Increasing evidence of novel regimens in trial settings has risen, but the combinations of oral shorter regimens have not been optimised. An evaluation of the efficacy and safety of short-term regimens utilizing various drug combinations is essential across different settings.
Methods: INSPIRE TB is a pragmatic, multicentre, randomised, controlled, non-inferiority open-label trial to evaluate novel regimens in pulmonary RR-TB patients of 16-75 years old with or without fluoroquinolone resistance. Before randomisation, an individualized assessment is conducted, considering drug susceptibility, contradictions, tolerance. Eligible participants are randomised based on fluoroquinolone susceptibility results from the Xpert MTB/XDR assay. Participants susceptible to fluoroquinolones are randomised to receive either one of seven different nine-month oral regimens or a nine-month standard-of-care regimen as the control. The experimental arms are five-drug regimens, each consisting of five agents selected from the following: bedaquiline, linezolid, a fluoroquinolone, cycloserine, clofazimine and pyrazinamide. Fluoroquinolone-resistant participants are randomised to either a 9-month oral regimen (bedaquiline, cycloserine, clofazimine, linezolid and pyrazinamide), or a 20-month conventional regimen as control in a 1:1 ratio. The primary outcome is the proportion of participants with a favourable…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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