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
  Purpose

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,


Condition Intervention Phase
Tuberculosis
Drug: Gatifloxacin combined regimen
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Institut de Recherche pour le Developpement:

Primary Outcome Measures:
  • Efficacy: Percentage of relapses by 24 months following treatment cure
  • Safety: Percentage of adverse events

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 2070
Study Start Date: January 2005
Estimated Study Completion Date: December 2008
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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00216385

Locations
Benin
Programme National de Lutte contre la Tuberculose Recruiting
Cotonou, Benin
Contact: Martin Gninafon, MD    + 229 33 15 33    pnt@intnet.bj   
Principal Investigator: Martin Gninafon, MD         
Guinea
Service Pneumo-Phtisiologie, CHU Ignace Deen Recruiting
Conakry, Guinea
Contact: Oumou Y Sow, MD    +224 41 20 58    prsow@kassa.sotelgui.net.gn   
Principal Investigator: Oumou Sow, MD         
Kenya
Kenya Medical Research Institute Recruiting
Nairobi, Kenya
Contact: Joseph Odhiambo, MD    + 254 02 71 30 08    jodhiambo@nairobi.mimcom.net   
Principal Investigator: Joseph Odhiambo, MD         
Senegal
Programme National de Lutte contre la Tuberculose Recruiting
Dakar, Senegal
Contact: Cheikh Seck, MD    + 221 824.90.09    cheikbaf@yahoo.fr   
Principal Investigator: Cheikh Seck, MD         
South Africa
Medical Research Council Recruiting
Durban, KwaZulu, South Africa
Contact: Roxana Rustomjee, MD    +27 31 207 16 75    Roxana.rustomjee@mrc.ac.za   
Principal Investigator: Roxana Rustomjee, MD         
Sponsors and Collaborators
Institut de Recherche pour le Developpement
World Health Organization
European Commission
Investigators
Study Director: Christian Lienhardt, MD Institut de Recherche pour le Developpement
  More Information

No publications provided by Institut de Recherche pour le Developpement

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00216385     History of Changes
Other Study ID Numbers: ICA4-CT 2002-10057
Study First Received: September 16, 2005
Last Updated: September 20, 2005
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Institut de Recherche pour le Developpement:
Tuberculosis
Treatment
Quinolone
Short course chemotherapy

Additional relevant MeSH terms:
Tuberculosis
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Gatifloxacin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014