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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00216385
Recruitment Status : Unknown
Verified September 2005 by Institut de Recherche pour le Developpement.
Recruitment status was:  Recruiting
First Posted : September 22, 2005
Last Update Posted : September 22, 2005
World Health Organization
European Commission
Information provided by:
Institut de Recherche pour le Developpement

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 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 or disease Intervention/treatment Phase
Tuberculosis Drug: Gatifloxacin combined regimen Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 2070 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2005
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

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

Secondary Outcome Measures :
  1. Efficacy: Time to relapse
  2. Efficacy: Percentage of smear and culture conversion at 8 weeks
  3. Efficacy: Percentage of patient cured at the end of treatment
  4. Efficacy: Time to a composite "unsatisfactory" endpoint
  5. Safety outcome: Distribution of type and grading of adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00216385

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Programme National de Lutte contre la Tuberculose Recruiting
Cotonou, Benin
Contact: Martin Gninafon, MD    + 229 33 15 33   
Principal Investigator: Martin Gninafon, MD         
Service Pneumo-Phtisiologie, CHU Ignace Deen Recruiting
Conakry, Guinea
Contact: Oumou Y Sow, MD    +224 41 20 58   
Principal Investigator: Oumou Sow, MD         
Kenya Medical Research Institute Recruiting
Nairobi, Kenya
Contact: Joseph Odhiambo, MD    + 254 02 71 30 08   
Principal Investigator: Joseph Odhiambo, MD         
Programme National de Lutte contre la Tuberculose Recruiting
Dakar, Senegal
Contact: Cheikh Seck, MD    + 221 824.90.09   
Principal Investigator: Cheikh Seck, MD         
South Africa
Medical Research Council Recruiting
Durban, KwaZulu, South Africa
Contact: Roxana Rustomjee, MD    +27 31 207 16 75   
Principal Investigator: Roxana Rustomjee, MD         
Sponsors and Collaborators
Institut de Recherche pour le Developpement
World Health Organization
European Commission
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Study Director: Christian Lienhardt, MD Institut de Recherche pour le Developpement
Publications automatically indexed to this study by Identifier (NCT Number):

Layout table for additonal information Identifier: NCT00216385    
Other Study ID Numbers: ICA4-CT 2002-10057
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 22, 2005
Last Verified: September 2005
Keywords provided by Institut de Recherche pour le Developpement:
Short course chemotherapy
Additional relevant MeSH terms:
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Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Ophthalmic Solutions
Pharmaceutical Solutions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents