Evaluation of two short standardised regimens for the treatment of rifampicin-resistant tuberculosis (STREAM stage 2): an open-label, multicentre, randomised, non-inferiority trial

Goodall, Ruth; Meredith, Sarah; Nunn, Andrew; Bayissa, Adamu; Bhatnagar, Anuj; Bronson, Gay; Chiang, Chifa; Conradie, Francesca; Gurumurthy, Meera; Kirenga, Bruce; Kiria, Nana; Meressa, Daniel; Moodliar, Ronelle; Narendran, Gopalan; Ngubane, Nosipho; Rassool, Mohammed; Sanders, Karen; Solanki, Rajesh; Squire, S Bertel; Torrea, Gabriela; Tsogt, Bazarragchaa; Tudor, Elena; Deun, Armand Van; Rusen, I. D.; Adilaa, Oyunchimeg; Alexandru, Sofia; Bellenger, Katharine; Bennet, J; Bennet, Deborah; Bindroo, Priyanka; Borisagar, Ghanshyam B.; Cook, Claire; Dalai, D.; Davis, Andrew M.; Jong, Bouke De; Dodds, Wendy; Duckworth, Lynette; Gahima, Nonhlanhla; Gebreegziabher, Belay; Goldfeld, Anne E.; Hanifa, Mahmud; Hughes, G.; Kimuli, Ivan; Komrska, Jan; Lomtadze, Nino; Murphy, Brendan; Mwelase, Thando; Nalunjogi, Joanitah; Patel, Leena; Pirlog, Irina; Qawiy, Ishmael; Rauchenberger, Mary; Rigouts, Leen; Roach, Carol; Rosu, Laura; Santos-Filho, Ezio; Senguttuvan, Thirumaran; Sisay, Million; Ramaswamy, Sridhar; Srinivasulu, Vignes; Teferi, Mekonnen; Teklu, Helen; Tsegeen, Narangarav; Amsterdam, Odette van; White, Lisa J.; Whitney, Johanna; Zagd, Chuluunbaatar

doi:10.1016/s0140-6736(22)02078-5

Cited by 69 publications

(48 citation statements)

References 14 publications

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“…The clinical trial design has been described in detail elsewhere. 7 In brief, STREAM stage 2 was an international, multicentre, non-inferiority randomised controlled trial done in 13 hospital clinics in seven countries (Ethiopia, Georgia, India, Moldova, Mongolia, South Africa, and Uganda). The Union Ethics Advisory Group was the global ethics committee.…”

Section: Study Design and Participantsmentioning

confidence: 99%

“…Randomisation to the 20-month and 6-month regimens ceased early at most sites. 7 The primary trial objective was to determine whether the proportion of participants in the modified intentionto-treat population with a favourable efficacy outcome at week 76 in the oral regimen group was non-inferior to that in the control group. Assessment of the 6-month regimen versus control was a secondary objective.…”

Section: Implications Of All the Available Evidencementioning

confidence: 99%

“…Health economic data were collected from four of the seven countries in STREAM stage 2: Ethiopia, India, Moldova, and Uganda. All participants who fulfilled the inclusion criteria as outlined in the trial protocol, 7 were older than 18 years, provided written informed consent, and responded to the health economic questionnaires at least once were included in the health economic study.…”

Section: Implications Of All the Available Evidencementioning

confidence: 99%

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Economic evaluation of shortened, bedaquiline-containing treatment regimens for rifampicin-resistant tuberculosis (STREAM stage 2): a within-trial analysis of a randomised controlled trial

Rosu

Madan

Tomeny

et al. 2023

The Lancet Global Health

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Section: Study Design and Participantsmentioning

confidence: 99%

Section: Implications Of All the Available Evidencementioning

confidence: 99%

Section: Implications Of All the Available Evidencementioning

confidence: 99%

See 1 more Smart Citation

Economic evaluation of shortened, bedaquiline-containing treatment regimens for rifampicin-resistant tuberculosis (STREAM stage 2): a within-trial analysis of a randomised controlled trial

Rosu

Madan

Tomeny

et al. 2023

The Lancet Global Health

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“…Stage 1 of the trial, implemented at seven sites in Ethiopia, Mongolia, South Africa, and Vietnam, was completed in 2017 and primary outcome results at 132 weeks of follow-up were published in 2019 [ 12 ]. Stage 2 of the trial commenced in 2016 and was implemented at 13 sites in Ethiopia, India, Georgia, Moldova, Mongolia, South Africa, and Uganda with primary outcome results at 76 weeks of follow-up published in November 2022 [ 13 ].…”

Section: Introductionmentioning

confidence: 99%

Implementation challenges and lessons learned from the STREAM clinical trial—a survey of trial sites

Patel

Gurumurthy²,

Bronson

et al. 2023

Trials

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Background Design and implementation of multi-country clinical trials for multidrug-resistant tuberculosis (MDR-TB) are complex for several reasons, including trial duration, varying levels of experience and infrastructure across settings, and different regulatory requirements. STREAM was an MDR-TB clinical trial that recruited over 1000 participants. We documented challenges and best practices/lessons learned from the site perspective to improve implementation of future trials. Methods We conducted a voluntary survey of trial staff at all sites to obtain information on challenges encountered and best practices/lessons learned from implementation of the STREAM trial. Respondents were asked to identify substantive aspects of trial implementation from a list that included: trial administration, laboratory strengthening/infrastructure, pharmacy and supply chain management, community engagement, regulatory and ethics requirements, health economics, and other (respondent designated) about which a practical guide would be useful to improve future trial implementation. For each aspect of trial implementation selected, respondents were asked to report challenges and best practices/lessons learned during STREAM. Lastly, respondents were asked to list up to three things they would do differently when implementing future trials. Summary statistics were generated for quantitative data and thematic analysis was undertaken for qualitative data. Results Of 67 responses received from 13 of 15 sites, 47 (70%) were included in the analyses, after excluding duplicate or incomplete responses. Approximately half the respondents were investigators or trial coordinators. The top three aspects of trial implementation identified for a best practices/lessons learned practical guide to improve future trial implementation were: trial administration, community engagement, and laboratory strengthening/infrastructure. For both challenges and best practices/lessons learned, three common themes were identified across different aspects of trial implementation. Investment in capacity building and ongoing monitoring; investment in infrastructure and well-designed trial processes; and communication and coordination between staff and meaningful engagement of stakeholders were all thought to be critical to successful trial implementation. Conclusions Existing practices for clinical trial implementation should be reevaluated. Sponsors should consider the local context and the need to increase upfront investment in the cross-cutting thematic areas identified to improve trial implementation.

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“…[ 7 ] Finally, the results of the STREAM Stage 2 study, just published, demonstrate that two short BDQ based regimens (one of 6 months including 2 months of injectable kanamycin, and the other, all-oral, of 9 months) were both superior to the longer regimen established to be effective in the earlier STREAM Stage 1 study. [ 8 ]…”

mentioning

confidence: 99%

New treatments for Drug Resistant TB

Udwadia

Patel²

2023

Lung India

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Evaluation of two short standardised regimens for the treatment of rifampicin-resistant tuberculosis (STREAM stage 2): an open-label, multicentre, randomised, non-inferiority trial

Cited by 69 publications

References 14 publications

Economic evaluation of shortened, bedaquiline-containing treatment regimens for rifampicin-resistant tuberculosis (STREAM stage 2): a within-trial analysis of a randomised controlled trial

Economic evaluation of shortened, bedaquiline-containing treatment regimens for rifampicin-resistant tuberculosis (STREAM stage 2): a within-trial analysis of a randomised controlled trial

Implementation challenges and lessons learned from the STREAM clinical trial—a survey of trial sites

New treatments for Drug Resistant TB

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