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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Evaluation of a standardized treatment regimen of anti-tuberculosis drugs for patients with multi-drug-resistant tuberculosis (STREAM): Study protocol for a randomized controlled trial
Trials, Volume 15, No. 1, Article 353, Year 2014
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Description
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 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.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 trial together with data from 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. © 2014 Nunn et al.; licensee BioMed Central Ltd.
Authors & Co-Authors
Nunn, Andrew J.
United Kingdom, London
Medical Research Council
Rusen, I. D.
France, Paris
International Union Against Tuberculosis and Lung Disease
van Deun, Armand
France, Paris
International Union Against Tuberculosis and Lung Disease
Belgium, Antwerpen
Prins Leopold Instituut Voor Tropische Geneeskunde
Torrea, Gabriela
Belgium, Antwerpen
Prins Leopold Instituut Voor Tropische Geneeskunde
Phillips, Patrick P.J.
United Kingdom, London
Medical Research Council
Chiang, Chenyuan
France, Paris
International Union Against Tuberculosis and Lung Disease
Taiwan, Taipei
Taipei Medical University
Squire, S. Bertel
United Kingdom, Liverpool
Liverpool School of Tropical Medicine
Madan, Jason J.
United Kingdom, Coventry
University of Warwick
Meredith, Sarah K.
United Kingdom, London
Medical Research Council
Statistics
Citations: 108
Authors: 9
Affiliations: 6
Identifiers
Doi:
10.1186/1745-6215-15-353
ISSN:
17456215
Research Areas
Infectious Diseases
Study Design
Randomised Control Trial
Cohort Study
Study Approach
Quantitative