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).
authors.affiliation: Medical Research Council Clinical Trials Unit at University College London, London, UK.
authors.forename: A J
authors.initials: AJ
authors.lastname: Nunn
authors.affiliation: International Union Against Tuberculosis and Lung Disease, Paris, France.
authors.forename: S V
authors.initials: SV
authors.lastname: Cook
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, University of New Mexico, Albuquerque, New Mexico, USA.
authors.forename: M
authors.initials: M
authors.lastname: Burgos
authors.affiliation: Mycobacteriology Unit, Institute of Tropical Medicine, Antwerp, Belgium.
authors.forename: L
authors.initials: L
authors.lastname: Rigouts
authors.affiliation: Medical Research Council Clinical Trials Unit at University College London, London, UK.
authors.forename: V
authors.initials: V
authors.lastname: Yorke-Edwards
authors.affiliation: American Society for Microbiology, Washington DC, USA.
authors.forename: G
authors.initials: G
authors.lastname: Anyo
authors.affiliation: Korean Institute of Tuberculosis, Osong, South Korea.
authors.forename: S-J
authors.initials: SJ
authors.lastname: Kim
authors.affiliation: International Union Against Tuberculosis and Lung Disease, Paris, France.
authors.forename: D A
authors.initials: DA
authors.lastname: Enarson
authors.affiliation: Department of Cellular and Molecular Medicine, St George's, University of London, London, UK.
authors.forename: A
authors.initials: A
authors.lastname: Jindani
authors.affiliation: Stop TB Partnership, World Health Organization, Geneva, Switzerland.
authors.forename: C
authors.initials: C
authors.lastname: Lienhardt
mesh_terms: D000349:Africa; D000995:Antitubercular Agents / Q000627:therapeutic use; D001208:Asia; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D004977:Ethambutol / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007538:Isoniazid / Q000627:therapeutic use; D007843:Latin America; D008297:Male; D011718:Pyrazinamide / Q000627:therapeutic use; D012008:Recurrence; D012293:Rifampin / Q000627:therapeutic use; D016896:Treatment Outcome; D018088:Tuberculosis, Multidrug-Resistant / Q000188:drug therapy; D014397:Tuberculosis, Pulmonary / Q000188:drug therapy*
chemical_list: D000995:Antitubercular Agents; D004338:Drug Combinations; D011718:Pyrazinamide; D004977:Ethambutol; D007538:Isoniazid; D012293:Rifampin