Results at 30 months of a randomised trial of FDCs and separate drugs for the treatment of tuberculosis

A J Nunn; S V Cook; M Burgos; L Rigouts; V Yorke-Edwards; G Anyo; S-J Kim; D A Enarson; A Jindani; C Lienhardt

doi:10.5588/ijtld.14.0281

Results at 30 months of a randomised trial of FDCs and separate drugs for the treatment of tuberculosis

A J Nunn, S V Cook, M Burgos, L Rigouts, V Yorke-Edwards, G Anyo, S-J Kim, D A Enarson, A Jindani, C Lienhardt

Mycobacteriology

Research output: Contribution to journal › A1: Web of Science-article › peer-review

Abstract

Study C was an open-label, non-inferiority, randomised controlled trial of fixed-dose combination (FDC) or separate drugs given during the intensive phase of treatment to 1585 patients with smear-positive pulmonary tuberculosis conducted at 11 sites in Africa, Asia and Latin America. Thirty months post-randomisation, the failure/relapse rates in the per protocol population were 7.4% of 591 patients on FDCs and 6.5% of 587 patients on separate drugs; the site-adjusted difference was 0.3% (90%CI -1.8 to 2.3). In the modified intention-to-treat analysis, the corresponding results were respectively 17.9% of 683 and 16.1% of 671; the site-adjusted difference was 2.0% (90%CI -1.2 to 5.2).

Original language	English
Journal	International Journal of Tuberculosis and Lung Disease
Volume	18
Issue number	10
Pages (from-to)	1252-1254
Number of pages	3
ISSN	1027-3719
DOIs	https://doi.org/10.5588/ijtld.14.0281
Publication status	Published - 2014

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10.5588/ijtld.14.0281

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title = "Results at 30 months of a randomised trial of FDCs and separate drugs for the treatment of tuberculosis",

abstract = "Study C was an open-label, non-inferiority, randomised controlled trial of fixed-dose combination (FDC) or separate drugs given during the intensive phase of treatment to 1585 patients with smear-positive pulmonary tuberculosis conducted at 11 sites in Africa, Asia and Latin America. Thirty months post-randomisation, the failure/relapse rates in the per protocol population were 7.4% of 591 patients on FDCs and 6.5% of 587 patients on separate drugs; the site-adjusted difference was 0.3% (90%CI -1.8 to 2.3). In the modified intention-to-treat analysis, the corresponding results were respectively 17.9% of 683 and 16.1% of 671; the site-adjusted difference was 2.0% (90%CI -1.2 to 5.2).",

keywords = "Africa, Antitubercular Agents, Asia, Dose-Response Relationship, Drug, Drug Combinations, Ethambutol, Female, Follow-Up Studies, Humans, Isoniazid, Latin America, Male, Pyrazinamide, Recurrence, Rifampin, Treatment Outcome, Tuberculosis, Multidrug-Resistant, Tuberculosis, Pulmonary",

author = "Nunn, {A J} and Cook, {S V} and M Burgos and L Rigouts and V Yorke-Edwards and G Anyo and S-J Kim and Enarson, {D A} and A Jindani and C Lienhardt",

year = "2014",

doi = "10.5588/ijtld.14.0281",

language = "English",

volume = "18",

pages = "1252--1254",

journal = "International Journal of Tuberculosis and Lung Disease",

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TY - JOUR

T1 - Results at 30 months of a randomised trial of FDCs and separate drugs for the treatment of tuberculosis

AU - Nunn, A J

AU - Cook, S V

AU - Burgos, M

AU - Rigouts, L

AU - Yorke-Edwards, V

AU - Anyo, G

AU - Kim, S-J

AU - Enarson, D A

AU - Jindani, A

AU - Lienhardt, C

PY - 2014

Y1 - 2014

N2 - Study C was an open-label, non-inferiority, randomised controlled trial of fixed-dose combination (FDC) or separate drugs given during the intensive phase of treatment to 1585 patients with smear-positive pulmonary tuberculosis conducted at 11 sites in Africa, Asia and Latin America. Thirty months post-randomisation, the failure/relapse rates in the per protocol population were 7.4% of 591 patients on FDCs and 6.5% of 587 patients on separate drugs; the site-adjusted difference was 0.3% (90%CI -1.8 to 2.3). In the modified intention-to-treat analysis, the corresponding results were respectively 17.9% of 683 and 16.1% of 671; the site-adjusted difference was 2.0% (90%CI -1.2 to 5.2).

AB - Study C was an open-label, non-inferiority, randomised controlled trial of fixed-dose combination (FDC) or separate drugs given during the intensive phase of treatment to 1585 patients with smear-positive pulmonary tuberculosis conducted at 11 sites in Africa, Asia and Latin America. Thirty months post-randomisation, the failure/relapse rates in the per protocol population were 7.4% of 591 patients on FDCs and 6.5% of 587 patients on separate drugs; the site-adjusted difference was 0.3% (90%CI -1.8 to 2.3). In the modified intention-to-treat analysis, the corresponding results were respectively 17.9% of 683 and 16.1% of 671; the site-adjusted difference was 2.0% (90%CI -1.2 to 5.2).

KW - Africa

KW - Antitubercular Agents

KW - Asia

KW - Dose-Response Relationship, Drug

KW - Drug Combinations

KW - Ethambutol

KW - Female

KW - Follow-Up Studies

KW - Humans

KW - Isoniazid

KW - Latin America

KW - Male

KW - Pyrazinamide

KW - Recurrence

KW - Rifampin

KW - Treatment Outcome

KW - Tuberculosis, Multidrug-Resistant

KW - Tuberculosis, Pulmonary

U2 - 10.5588/ijtld.14.0281

DO - 10.5588/ijtld.14.0281

M3 - A1: Web of Science-article

C2 - 25216842

SN - 1027-3719

VL - 18

SP - 1252

EP - 1254

JO - International Journal of Tuberculosis and Lung Disease

JF - International Journal of Tuberculosis and Lung Disease

IS - 10

ER -

Results at 30 months of a randomised trial of FDCs and separate drugs for the treatment of tuberculosis

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