Results at 30 months of a randomised trial of FDCs and separate drugs for the treatment of tuberculosisResults at 30 months of a randomised trial of FDCs and separate drugs for the treatment of tuberculosis
Faculty of Pharmaceutical, Biomedical and Veterinary Sciences. Pharmacy
Laboratory for Microbiology, Parasitology and Hygiene (LMPH)
International journal of tuberculosis and lung disease. - Paris
18(2014):10, p. 1252-1254
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).