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Comparing the Efficacy of Drug Regimens for Pulmonary Tuberculosis: Meta-analysis of Endpoints in Early-Phase Clinical Trials

BACKGROUND: A systematic review of early clinical outcomes in tuberculosis was undertaken to determine ranking of efficacy of drugs and combinations, define variability of these measures on different endpoints, and to establish the relationships between them. METHODS: Studies were identified by sear...

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Detalles Bibliográficos
Autores principales: Bonnett, Laura J, Ken-Dror, Gie, Koh, Gavin C K W, Davies, Geraint R
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5850317/
https://www.ncbi.nlm.nih.gov/pubmed/28402396
http://dx.doi.org/10.1093/cid/cix247
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author Bonnett, Laura J
Ken-Dror, Gie
Koh, Gavin C K W
Davies, Geraint R
author_facet Bonnett, Laura J
Ken-Dror, Gie
Koh, Gavin C K W
Davies, Geraint R
author_sort Bonnett, Laura J
collection PubMed
description BACKGROUND: A systematic review of early clinical outcomes in tuberculosis was undertaken to determine ranking of efficacy of drugs and combinations, define variability of these measures on different endpoints, and to establish the relationships between them. METHODS: Studies were identified by searching PubMed, Medline, Embase, LILACS (Latin American and Caribbean Health Sciences Literature), and reference lists of included studies. Outcomes were early bactericidal activity results over 2, 7, and 14 days, and the proportion of patients with negative culture at 8 weeks. RESULTS: One hundred thirty-three trials reporting phase 2A (early bactericidal activity) and phase 2B (culture conversion at 2 months) outcomes were identified. Only 9 drug combinations were assessed on >1 phase 2A endpoint and only 3 were assessed in both phase 2A and 2B trials. CONCLUSIONS: The existing evidence base supporting phase 2 methodology in tuberculosis is highly incomplete. In future, a broader range of drugs and combinations should be more consistently studied across a greater range of phase 2 endpoints.
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spelling pubmed-58503172018-03-23 Comparing the Efficacy of Drug Regimens for Pulmonary Tuberculosis: Meta-analysis of Endpoints in Early-Phase Clinical Trials Bonnett, Laura J Ken-Dror, Gie Koh, Gavin C K W Davies, Geraint R Clin Infect Dis Articles and Commentaries BACKGROUND: A systematic review of early clinical outcomes in tuberculosis was undertaken to determine ranking of efficacy of drugs and combinations, define variability of these measures on different endpoints, and to establish the relationships between them. METHODS: Studies were identified by searching PubMed, Medline, Embase, LILACS (Latin American and Caribbean Health Sciences Literature), and reference lists of included studies. Outcomes were early bactericidal activity results over 2, 7, and 14 days, and the proportion of patients with negative culture at 8 weeks. RESULTS: One hundred thirty-three trials reporting phase 2A (early bactericidal activity) and phase 2B (culture conversion at 2 months) outcomes were identified. Only 9 drug combinations were assessed on >1 phase 2A endpoint and only 3 were assessed in both phase 2A and 2B trials. CONCLUSIONS: The existing evidence base supporting phase 2 methodology in tuberculosis is highly incomplete. In future, a broader range of drugs and combinations should be more consistently studied across a greater range of phase 2 endpoints. Oxford University Press 2017-07-01 2017-04-10 /pmc/articles/PMC5850317/ /pubmed/28402396 http://dx.doi.org/10.1093/cid/cix247 Text en © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. http://creativecommons.org/licenses/by-nc-nd/4.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Articles and Commentaries
Bonnett, Laura J
Ken-Dror, Gie
Koh, Gavin C K W
Davies, Geraint R
Comparing the Efficacy of Drug Regimens for Pulmonary Tuberculosis: Meta-analysis of Endpoints in Early-Phase Clinical Trials
title Comparing the Efficacy of Drug Regimens for Pulmonary Tuberculosis: Meta-analysis of Endpoints in Early-Phase Clinical Trials
title_full Comparing the Efficacy of Drug Regimens for Pulmonary Tuberculosis: Meta-analysis of Endpoints in Early-Phase Clinical Trials
title_fullStr Comparing the Efficacy of Drug Regimens for Pulmonary Tuberculosis: Meta-analysis of Endpoints in Early-Phase Clinical Trials
title_full_unstemmed Comparing the Efficacy of Drug Regimens for Pulmonary Tuberculosis: Meta-analysis of Endpoints in Early-Phase Clinical Trials
title_short Comparing the Efficacy of Drug Regimens for Pulmonary Tuberculosis: Meta-analysis of Endpoints in Early-Phase Clinical Trials
title_sort comparing the efficacy of drug regimens for pulmonary tuberculosis: meta-analysis of endpoints in early-phase clinical trials
topic Articles and Commentaries
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5850317/
https://www.ncbi.nlm.nih.gov/pubmed/28402396
http://dx.doi.org/10.1093/cid/cix247
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