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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Keeping up with the guidelines: design changes to the STREAM stage 2 randomised controlled non-inferiority trial for rifampicin-resistant tuberculosis
Trials, Volume 23, No. 1, Article 474, Year 2022
Notification
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Description
Results from the STREAM stage 1 trial showed that a 9-month regimen for patients with rifampicin-resistant tuberculosis was non-inferior to the 20-month regimen recommended by the 2011 WHO treatment guidelines. Similar levels of severe adverse events were reported on both regimens suggesting the need for further research to optimise treatment. Stage 2 of STREAM evaluates two additional short-course regimens, both of which include bedaquiline. Throughout stage 2 of STREAM, new drug choices and a rapidly changing treatment landscape have necessitated changes to the trial’s design to ensure it remains ethical and relevant. This paper describes changes to the trial design to ensure that stage 2 continues to answer important questions. These changes include the early closure to recruitment of two trial arms and an adjustment to the definition of the primary endpoint. If the STREAM experimental regimens are shown to be non-inferior or superior to the stage 1 study regimen, this would represent an important contribution to evidence about potentially more tolerable and more efficacious MDR-TB regimens, and a welcome advance for patients with rifampicin-resistant tuberculosis and tuberculosis control programmes globally. Trial registration: ISRCTN ISRCTN18148631. Registered 10 February 2016. © 2022, The Author(s).
Authors & Co-Authors
Goodall, Ruth L.
United Kingdom, London
Mrc Clinical Trials Unit
Sanders, Karen
United Kingdom, London
Mrc Clinical Trials Unit
Bronson, Gay
United States, New York
Vital Strategies
Gurumurthy, Meera
Singapore, Singapore City
Vital Strategies
Torrea, Gabriela
Belgium, Antwerpen
Prins Leopold Instituut Voor Tropische Geneeskunde
Meredith, Sarah K.
United Kingdom, London
Mrc Clinical Trials Unit
Nunn, Andrew J.
United Kingdom, London
Mrc Clinical Trials Unit
Rusen, I. D.
United States, New York
Vital Strategies
Komrska, Jan
Unknown Affiliation
Patel, Leena N.
Unknown Affiliation
Qawiy, Ishmael
Unknown Affiliation
Bellenger, Katharine
Unknown Affiliation
Bennet, Deborah H.
Unknown Affiliation
Dodds, Wendy
Unknown Affiliation
Goodall, Ruth
Unknown Affiliation
Murphy, Brendan
Unknown Affiliation
Roach, Carol
Unknown Affiliation
Whitney, Johanna
Unknown Affiliation
van Deun, Armand
Unknown Affiliation
Chiang, Chenyuan
Unknown Affiliation
Rosu, Laura
Unknown Affiliation
Squire, S. Bertel
Unknown Affiliation
Madan, Jason J.
Unknown Affiliation
Statistics
Citations: 2
Authors: 23
Affiliations: 4
Identifiers
Doi:
10.1186/s13063-022-06397-4
ISSN:
17456215
Research Areas
Infectious Diseases
Study Design
Randomised Control Trial