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

September 20, 2005 updated by: Institut de Recherche pour le Developpement

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,

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

2070

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Benin
      • Cotonou, Benin
        • Recruiting
        • Programme National de Lutte contre la Tuberculose
        • Contact:
          • Martin Gninafon, MD
          • Phone Number: + 229 33 15 33
          • Email: pnt@intnet.bj
        • Principal Investigator:
          • Martin Gninafon, MD
  • Guinea
      • Conakry, Guinea
        • Recruiting
        • Service Pneumo-Phtisiologie, CHU Ignace Deen
        • Contact:
        • Principal Investigator:
          • Oumou Sow, MD
  • Kenya
      • Nairobi, Kenya
        • Recruiting
        • Kenya Medical Research Institute
        • Contact:
        • Principal Investigator:
          • Joseph Odhiambo, MD
  • Senegal
      • Dakar, Senegal
        • Recruiting
        • Programme National de Lutte contre la Tuberculose
        • Contact:
        • Principal Investigator:
          • Cheikh Seck, MD
  • South Africa
    • KwaZulu
      • Durban, KwaZulu, South Africa
        • Recruiting
        • Medical Research Council
        • Contact:
        • Principal Investigator:
          • Roxana Rustomjee, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Efficacy: Percentage of relapses by 24 months following treatment cure
Safety: Percentage of adverse events

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Recherche pour le Developpement

Collaborators

World Health Organization
European Commission

Investigators

  • Study Director: Christian Lienhardt, MD, Institut de Recherche pour le Developpement

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Study Completion

December 1, 2008

Study Registration Dates

First Submitted

September 16, 2005

First Submitted That Met QC Criteria

September 20, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

September 22, 2005

Last Update Submitted That Met QC Criteria

September 20, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICA4-CT 2002-10057

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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