The Evaluation of a Standardised Treatment Regimen of anti-Tuberculosis Drugs for Patients with MDR-TB (STREAM): study protocol for a randomised controlled trial

Background:
\nIn contrast to drug-sensitive tuberculosis, the guidelines for the treatment of multi-drug-resistant
\ntuberculosis (MDR-TB) have a very poor evidence base; current recommendations, based on expert opinion, are
\nthat patients should be treated for a minimum of 20 months. A series of cohort studies conducted in Bangladesh
\nidentified a nine-month regimen with very promising results. There is a need to evaluate this regimen in comparison
\nwith the currently recommended regimen in a randomized controlled trial in a variety of settings, including patients
\nwith HIV-coinfection.
\nMethods/Design:
\nSTREAM is a multi-centre randomized trial of n
\non-inferiority design comparing a nine-month
\nregimen to the treatment currently recommended by th
\ne World Health Organization in patients with MDR
\npulmonary TB with no evidence on line probe assay of fluoroquinolone or kanamycin resistance. The nine-month
\nregimen includes clofazimine…