STREAM Stage 1

STREAM stage 1 was a phase 3 non-inferiority trial in participants with rifampin-resistant tuberculosis that was susceptible to fluoroquinolones and aminoglycosides. Participants were randomly assigned, in a 2:1 ratio, to receive a short regimen (9 to 11 months) that included high-dose moxifloxacin or a long regimen (20 months) that followed the 2011 WHO guidelines. The primary efficacy outcome was a favourable status at 132 weeks, defined by cultures negative for Mycobacterium tuberculosis at 132 weeks and at a previous occasion, with no intervening positive culture or previous unfavourable outcome. The results showed that the 9-11 month regimen was statistically non-inferior to the 20-24 month regimen. 78.8 percent of assessable participants in the 9-11 month regimen had a favourable outcome, compared to 79.8 percent in the longer regimen. The two regimens had similar levels of severe side-effects. Further details can be found in the NEJM publication of the main trial results: https://www.nejm.org/doi/full/10.1056/NEJMoa1811867