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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Institut de Recherche pour le Developpement.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
World Health Organization
European Commission
Information provided by:
Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier:
NCT00216385
First received: September 16, 2005
Last updated: September 20, 2005
Last verified: September 2005

September 16, 2005
September 20, 2005
January 2005
Not Provided
  • Efficacy: Percentage of relapses by 24 months following treatment cure
  • Safety: Percentage of adverse events
Same as current
Complete list of historical versions of study NCT00216385 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
A Controlled Trial of a 4-Month Quinolone-Containing Regimen for the Treatment of Pulmonary Tuberculosis
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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Tuberculosis
Drug: Gatifloxacin combined regimen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2070
December 2008
Not Provided

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.
Both
18 Years to 65 Years
No
Benin,   Guinea,   Kenya,   Senegal,   South Africa
 
NCT00216385
ICA4-CT 2002-10057
Not Provided
Not Provided
Institut de Recherche pour le Developpement
  • World Health Organization
  • European Commission
Study Director: Christian Lienhardt, MD Institut de Recherche pour le Developpement
Institut de Recherche pour le Developpement
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP