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

Tuberculosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00216385
• Other study ID #: ICA4-CT 2002-10057
• Status: Recruiting
• Phase: Phase 3
• First received: September 16, 2005
• Last updated: September 20, 2005
• Start date: January 2005
• Est. completion date: December 2008

Study information

• Verified date: September 2005
• Source: Institut de Recherche pour le Developpement
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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,

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2070
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

Drug:
• Gatifloxacin combined regimen

Locations

Country	Name	City	State
Benin	Programme National de Lutte contre la Tuberculose	Cotonou
Guinea	Service Pneumo-Phtisiologie, CHU Ignace Deen	Conakry
Kenya	Kenya Medical Research Institute	Nairobi
Senegal	Programme National de Lutte contre la Tuberculose	Dakar
South Africa	Medical Research Council	Durban	KwaZulu

Sponsors (3)

Lead Sponsor	Collaborator
Institut de Recherche pour le Developpement	European Commission, World Health Organization

Countries where clinical trial is conducted

Benin,  Guinea,  Kenya,  Senegal,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Percentage of relapses by 24 months following treatment cure
Primary	Safety: Percentage of adverse events
Secondary	Efficacy: Time to relapse
Secondary	Efficacy: Percentage of smear and culture conversion at 8 weeks
Secondary	Efficacy: Percentage of patient cured at the end of treatment
Secondary	Efficacy: Time to a composite “unsatisfactory” endpoint
Secondary	Safety outcome: Distribution of type and grading of adverse events