Drug-resistant tuberculosis treatments, the case for a phase III platform trial.
| Autor: | Yates TA; Institute of Health Informatics, University College London, 222 Euston Road, LondonNW1 2DA, England., Barnes S; UK Academics and Professionals to end TB, United Kingdom of Great Britain and Northern Ireland., Dedicoat M; Department of Infectious Diseases, University Hospitals Birmingham NHS Foundation Trust, Birmingham, England., Kon OM; National Heart and Lung Institute, Imperial College London, London, England., Kunst H; Blizard Institute, Queen Mary University of London, London, England., Lipman M; Faculty of Medical Sciences, University College London, London, England., Millington KA; Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, England., Nunn AJ; Medical Research Council Clinical Trials Unit at UCL, University College London, London, England., Phillips PP; UCSF Center for Tuberculosis, University of California San Francisco, San Francisco, United States of America., Potter JL; Faculty of Medical Sciences, University College London, London, England., Squire SB; Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, England. |
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| Jazyk: | angličtina |
| Zdroj: | Bulletin of the World Health Organization [Bull World Health Organ] 2024 Sep 01; Vol. 102 (9), pp. 657-664. |
| DOI: | 10.2471/BLT.23.290948 |
| Abstrakt: | Most phase III trials in drug-resistant tuberculosis have either been underpowered to quantify differences in microbiological endpoints or have taken up to a decade to complete. Composite primary endpoints, dominated by differences in treatment discontinuation and regimen changes, may mask important differences in treatment failure and relapse. Although new regimens for drug-resistant tuberculosis appear very effective, resistance to new drugs is emerging rapidly. There is a need for shorter, safer and more tolerable regimens, including those active against bedaquiline-resistant tuberculosis. Transitioning from multiple regimen A versus regimen B trials to a single large phase III platform trial would accelerate the acquisition of robust estimates of relative efficacy and safety. Further efficiencies could be achieved by adopting modern adaptive platform designs. Collaboration among trialists, affected community representatives, funders and regulators is essential for developing such a phase III platform trial for drug-resistant tuberculosis treatment regimens. ((c) 2024 The authors; licensee World Health Organization.) |
| Databáze: | MEDLINE |
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