NCT00216385

A Controlled Trial of a 4-Month Quinolone-Containing Regimen for the Treatment of Pulmonary Tuberculosis

A Randomised Open-Label Controlled Trial of a 4-Month Gatifloxacin-Containing Regimen Versus Standard Regimen for the Treatment of Adult Patients With Pulmonary Tuberculosis

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,070 (planned)
• Sponsor: Institut de Recherche pour le Developpement · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Tuberculosis is currently treated with a 6-month course regimen. During this time many patients might fail to adhere to treatment and default, increasing the risk of recurrent disease which might be multidrug resistant. A shorter duration of treatment is expected to provide improved patient compliance and at least equal or better clinical outcome. The aim of the trial is to evaluate the efficacy and safety of a gatifloxacin-containing regimen of four months duration for the treatment of pulmonary tuberculosis,

Detailed description

In order to evaluate the efficacy and safety of the 4-month test gatifloxacin-containing regimen, comparison will be made with a standard 6-month regimen, recommended by WHO. Patients will be treated with one of the two regimens that will be randomly allocated. A total of 2070 patients will ne recruited in the trial and followed-up for a duration of 2 years. The trial is multicentre, and conducted in 5 countries in Africa.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
DRUG	Gatifloxacin combined regimen

Timeline

• Start date: 2005-01-01
• Completion: 2008-12-01
• First posted: 2005-09-22
• Last updated: 2005-09-22

Locations

5 sites across 5 countries: Benin, Guinea, Kenya, Senegal, South Africa