Trial reportTrials2014
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.
Trial report in Trials, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 57 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
57 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Examining family planning and adverse pregnancy outcomes for women with active tuberculosis disease: a systematic review.BMJ open · 2022Pooled it
- Economic evaluation of short treatment for multidrug-resistant tuberculosis, Ethiopia and South Africa: the STREAM trial.Bulletin of the World Health Organization · 2020Trial
- Article
- Traditional and Short Course Treatment for Multidrug-Resistant Tuberculosis: A Comparative Study in National Referral Centers.Tanaffos · 2025Article
- Unlocking the potential of miRNAs in detecting pulmonary tuberculosis: prospects and pitfalls.Expert reviews in molecular medicine · 2024Review
- Novel Prodrug Strategies for the Treatment of Tuberculosis.Chemistry, an Asian journal · 2024Review
- HIV and body mass index are associated with prolonged corrected QT interval among people with drug-resistant tuberculosis on bedaquiline-containing regimen in Uganda.IJID regions · 2024Article
- Ascertainment Bias in TB Treatment Trials: Can Systematic Assessment of Objective Endpoints Solve It?American journal of respiratory and critical care medicine · 2023Article
- New and Repurposed Drugs for the Treatment of Active Tuberculosis: An Update for Clinicians.Respiration; international review of thoracic diseases · 2023Review
- Rethinking intercurrent events in defining estimands for tuberculosis trials.Clinical trials (London, England) · 2022Article
- Article
- Social and health factors associated with adverse treatment outcomes among people with multidrug-resistant tuberculosis in Sierra Leone: a national, retrospective cohort study.The Lancet. Global health · 2022Article
- Updating the approaches to define susceptibility and resistance to anti-tuberculosis agents: implications for diagnosis and treatment.The European respiratory journal · 2022Article
- Comparative effectiveness of individualized longer and standardized shorter regimens in the treatment of multidrug resistant tuberculosis in a high burden country.Frontiers in pharmacology · 2022Article
- Population Pharmacokinetics of Levofloxacin and Moxifloxacin, and the Probability of Target Attainment in Ethiopian Patients with Multidrug-Resistant Tuberculosis.Infection and drug resistance · 2022Article
- Effectiveness of GenoType MTBDRThe international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2021Article
- Treatment outcomes of patients with multidrug and extensively drug-resistant tuberculosis in Zhejiang, China.European journal of medical research · 2021Article
- Article
- Investigation of the efficacy of the short regimen for rifampicin-resistant TB from the STREAM trial.BMC medicine · 2020Article
- A model-based analysis identifies differences in phenotypic resistance between in vitro and in vivo: implications for translational medicine within tuberculosis.Journal of pharmacokinetics and pharmacodynamics · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
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. 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 registrationThis trial was registered with clincaltrials.gov (registration number: ISRCTN78372190) on 14 October 2010.
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