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

This study is currently recruiting participants.

Verified by Institut de Recherche pour le Developpement, September 2005

Sponsors and Collaborators:	Institut de Recherche pour le Developpement World Health Organization European Commission
Information provided by:	Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier:	NCT00216385

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 III

MedlinePlus related topics: Tuberculosis

Drug Information available for: Gatifloxacin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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

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, KwaZulu
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

Study ID Numbers:	ICA4-CT 2002-10057
Study First Received:	September 16, 2005
Last Updated:	September 20, 2005
ClinicalTrials.gov Identifier:	NCT00216385
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

Study placed in the following topic categories:

Bacterial Infections
Gram-Positive Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Tuberculosis, pulmonary

Lung Diseases
Tuberculosis, Pulmonary
Mycobacterium Infections
Tuberculosis
Gatifloxacin

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 14, 2009