Title
Results at 30 months of a randomised trial of FDCs and separate drugs for the treatment of tuberculosis
Author
Faculty/Department
Faculty of Pharmaceutical, Biomedical and Veterinary Sciences. Pharmacy
Publication type
article
Publication
Paris ,
Subject
Human medicine
Source (journal)
International journal of tuberculosis and lung disease. - Paris
Volume/pages
18(2014) :10 , p. 1252-1254
ISSN
1027-3719
Carrier
E
Target language
English (eng)
Full text (Publishers DOI)
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).