9 research outputs found
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:
In 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/Design:
STREAM is a multi-centre randomized trial of n
on-inferiority design comparing a nine-month
regimen to the treatment currently recommended by th
e 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.
Discussion:
The 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 t
rial together with data fr
om ongoing cohorts should
provide the evidence necessary to revise current recommendations for the treatment for MDR-TB.
Trial registration:
This trial was registered with clincaltrials.gov (registration number: ISRCTN78372190) on 14 October 2010