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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00216385
Other study ID # ICA4-CT 2002-10057
Secondary ID
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
Est. primary completion date
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


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
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