NCT00216385.

Trial name or title	A controlled trial of a 4‐month quinolone‐containing regimen for the treatment of pulmonary TB OFLOTUB III
Methods	—
Participants	Inclusion criteria: male or female; aged 18 to 65 years; currently suffering from recently diagnosed microscopically proven pulmonary TB and providing informed consent for inclusion in the study. Exclusion criteria: history of TB treatment within the last 3 years; history of diabetes mellitus or non‐insulin dependent diabetes mellitus requiring treatment; concomitant infection requiring additional anti‐infective treatment (especially antiretroviral therapy); HIV‐ infected patients with WHO stage 3 infection ‐ except those presenting with only the "loss of weight > 10% body weight" criterion ‐ and all HIV infected patients at WHO stage 4.
Interventions	1. 4‐month gatifloxacin‐containing antituberculous regimen 2. Standard antituberculous regimen
Outcomes	1. Percentage of relapses by 24 months following treatment cure. 2. Percentage of adverse events. 3. Time to relapse. 4. Percentage of smear and culture conversion at 8 weeks. 5. Percentage of patient cured at the end 6. of treatment. 7. Time to a composite "unsatisfactory" endpoint. 8. Distribution of type and grading of adverse events.
Starting date	January 2005
Contact information	Christian Lienhardt (Study Director), Institut de Recherche pour le Developpement, France
Notes	Location: Benin, Guinea, Kenya, Senegal, South Africa Registration number: NCT00216385 Sponsors and collaborators: Institut de Recherche pour le Developpement; WHO; European Commission