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

Int J Tuberc Lung Dis. 2014 Oct;18(10):1252-4. doi: 10.5588/ijtld.14.0281.

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).

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Africa
  • Antitubercular Agents / therapeutic use
  • Asia
  • Dose-Response Relationship, Drug
  • Drug Combinations
  • Ethambutol / therapeutic use
  • Female
  • Follow-Up Studies
  • Humans
  • Isoniazid / therapeutic use
  • Latin America
  • Male
  • Pyrazinamide / therapeutic use
  • Recurrence
  • Rifampin / therapeutic use
  • Treatment Outcome
  • Tuberculosis, Multidrug-Resistant / drug therapy
  • Tuberculosis, Pulmonary / drug therapy*

Substances

  • Antitubercular Agents
  • Drug Combinations
  • Pyrazinamide
  • Ethambutol
  • Isoniazid
  • Rifampin

Associated data

  • ISRCTN/ISRCTN19832141