Multidrug-resistant TB (MDR-TB) is caused by tuberculosis (TB) bacteria resistant to at least isoniazid and rifampicin, the two most potent TB drugs. In STREAM Stage 2, the first large-scale, multi-country phase III clinical trial of shortened treatment regimens for MDR-TB, a 9-month all oral regimen containing bedaquiline and a 6-month regimen containing injectable and bedaquiline, and both containing a 4th generation fluoroquinolone, were found to be safe and effective. Primary outcome results provide high-quality evidence that support the current WHO recommendation of 9-month, all oral bedaquiline-containing regimens for drug-resistant TB.
The trial, sponsored by Vital Strategies and implemented between 2016-2022, enrolled and followed up 588 participants in 13 sites across Ethiopia, Georgia, India, Moldova, Mongolia, South Africa, and Uganda. As collaborator and reference laboratory, ITM’s Unit of Mycobacteriology was responsible for training and monitoring of the site microbiology laboratories, and for the central bacteriological analyses to determine the resistance patterns of the M. tuberculosis isolates, and to ascertain true relapse or failure.
STREAM Stage 2 was jointly funded by the United States Agency for International Development and Janssen Research & Development, LLC. Additional funding for STREAM was provided by the Medical Research Council and the UK Department for International Development under the MRC/DFID Concordat agreement and is also part of the EDCTP2 programme supported by the European Union.
Goodall et al. Evaluation of two short, standardised regimens for the treatment of rifampicin-resistant tuberculosis (STREAM stage 2): an open-label, multicentre, randomised, non-inferiority trial, The Lancet, 2022