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

Institut de Recherche pour le Developpement2,070 enrolled

Overview

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,

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

2,070

Conditions

Tuberculosis

Interventions

Gatifloxacin combined regimenDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (5)

Programme National de Lutte contre la Tuberculose

Cotonou, Benin

RECRUITING

Service Pneumo-Phtisiologie, CHU Ignace Deen

Conakry, Guinea

RECRUITING

Kenya Medical Research Institute

Nairobi, Kenya

Outcomes

Primary Outcomes

Efficacy: Percentage of relapses by 24 months following treatment cure

Safety: Percentage of adverse events

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.