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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Tuberculosis

Intervention / Treatment
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* Drug: Gatifloxacin combined regimen


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gatifloxacin combined regimen|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Percentage of relapses by 24 months following treatment cure |  |  | 
| Safety: Percentage of adverse events |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tuberculosis, Treatment, Quinolone, Short course chemotherapy