Abstract
BackgroundIn contrast to drug-sensitive tuberculosis, the guidelines for the treatment of multi-drug-resistant tuberculosis (MDR-TB) have a very poor evidence base; current recommendations, based on expert opinion, are that patients should be treated for a minimum of 20 months. A series of cohort studies conducted in Bangladesh identified a nine-month regimen with very promising results. There is a need to evaluate this regimen in comparison with the currently recommended regimen in a randomized controlled trial in a variety of settings, including patients with HIV-coinfection.Methods/DesignSTREAM is a multi-centre randomized trial of non-inferiority design comparing a nine-month regimen to the treatment currently recommended by the World Health Organization in patients with MDR pulmonary TB with no evidence on line probe assay of fluoroquinolone or kanamycin resistance. The nine-month regimen includes clofazimine and high-dose moxifloxacin and can be extended to 11 months in the event of delay in smear conversion. The primary outcome is based on the bacteriological status of the patients at 27 months post-randomization. Based on the assumption that the nine-month regimen will be slightly more effective than the control regimen and, given a 10% margin of non-inferiority, a total of 400 patients are required to be enrolled. Health economics data are being collected on all patients in selected sites.DiscussionThe results from the study in Bangladesh and cohorts in progress elsewhere are encouraging, but for this regimen to be recommended more widely than in a research setting, robust evidence is needed from a randomized clinical trial. Results from the STREAM trial together with data from ongoing cohorts should provide the evidence necessary to revise current recommendations for the treatment for MDR-TB.Trial registrationThis trial was registered with clincaltrials.gov (registration number: ISRCTN78372190) on 14 October 2010.
Highlights
Tuberculosis (TB) that is sensitive to standard drugs is a curable disease; most patients can be treated effectively and inexpensively in six months with a regimen that is based on rifampicin and isoniazid
A study carried out in Bangladesh by Van Deun et al published in 2010 reported good success rates in a cohort of over 200 patients with multi-drug-resistant tuberculosis (MDR-TB) treated with a standardized regimen given for only nine months [4]
This paper describes the design of the STREAM trial, explaining the background and rationale
Summary
In 1971 Cochrane gave TB the accolade of having the best evidence base for treatment of any disease and went on to say that the way in which new treatments for TB were introduced could serve as a model for all new treatments in future [27]. In the meantime additional cohorts assessing a regimen the same or similar to that studied in Bangladesh are being enrolled in several counties, mainly from sub-Saharan Africa [28,29]. One advantage of this parallel assessment will be that when the trial results are reported there will be additional data from studies conducted under program conditions. They remain necessary to provide reliable evidence to inform policymakers and give confidence to their recommendations, credit must be given to the Bangladesh study for identifying the nine-month regimen and generating the hypotheses that are being critically evaluated in the STREAM trial.
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