Official Title: “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”

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,

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Gatifloxacin combined regimen

Primary Measures

• Efficacy: Percentage of relapses by 24 months following treatment cure
• Safety: Percentage of adverse events

Secondary Measures

• Efficacy: Time to relapse
• Efficacy: Percentage of smear and culture conversion at 8 weeks
• Efficacy: Percentage of patient cured at the end of treatment
• Efficacy: Time to a composite “unsatisfactory” endpoint
• Safety outcome: Distribution of type and grading of adverse events

Inclusion Criteria:

• Male or female patients
• Aged 18 to 65 years
• Currently suffering from recently diagnosed microscopically proven pulmonary tuberculosis and providing informed consent for inclusion in the study.

Exclusion Criteria:

• Patients with history of tuberculosis 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 anti-retroviral 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Institut de Recherche pour le Developpement

Overall Clinical Trial Officials and Contacts

Christian Lienhardt, MD Study Director Institut de Recherche pour le Developpement  

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00216385

Study ID Number: ICA4-CT 2002-10057

ClinicalTrials.gov Identifier: NCT00216385

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency