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

Phase 3

• Conditions: Tuberculosis

• Registration Number: NCT00216385
• Lead Sponsor: Institut de Recherche pour le Developpement

Brief 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.

Study Timeline

• Study Start: 2005-01
• Status Verified: 2005-09
• Study First Submitted: 2005-09-16
• Study First Submitted QC: 2005-09-20
• Last Update Submitted: 2005-09-20
• Study First Posted: 2005-09-22
• Last Update Posted: 2005-09-22
• Study Completion: 2008-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2070

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Efficacy: Percentage of relapses by 24 months following treatment cure
Safety: Percentage of adverse events

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Service Pneumo-Phtisiologie, CHU Ignace Deen; 🇬🇳 Conakry, Guinea

Kenya Medical Research Institute; 🇰🇪 Nairobi, Kenya

Medical Research Council; 🇿🇦 Durban, KwaZulu, South Africa

Programme National de Lutte contre la Tuberculose; 🇸🇳 Dakar, Senegal