Status:
UNKNOWN
A Controlled Trial of a 4-Month Quinolone-Containing Regimen for the Treatment of Pulmonary Tuberculosis
Lead Sponsor:
Institut de Recherche pour le Developpement
Collaborating Sponsors:
World Health Organization
European Commission
Conditions:
Tuberculosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 m...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2008
Estimated Enrollment :
2070 Patients enrolled
Trial Details
Trial ID
NCT00216385
Start Date
January 1 2005
End Date
December 1 2008
Last Update
September 22 2005
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Programme National de Lutte contre la Tuberculose
Cotonou, Benin
2
Service Pneumo-Phtisiologie, CHU Ignace Deen
Conakry, Guinea
3
Kenya Medical Research Institute
Nairobi, Kenya
4
Programme National de Lutte contre la Tuberculose
Dakar, Senegal