A Controlled Trial of a 4-Month Quinolone-Containing Regimen for the Treatment of Pulmonary Tuberculosis
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ClinicalTrials.gov 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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tuberculosis | Drug: Gatifloxacin combined regimen | Phase 3 |
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 |

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

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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.

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 ClinicalTrials.gov identifier (NCT number): NCT00216385
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 |
Study Director: | Christian Lienhardt, MD | Institut de Recherche pour le Developpement |
ClinicalTrials.gov 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 |
Tuberculosis Treatment Quinolone Short course chemotherapy |
Tuberculosis Tuberculosis, Pulmonary Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections Respiratory Tract Infections Lung Diseases Respiratory Tract Diseases |
Gatifloxacin Anti-Bacterial Agents Anti-Infective Agents Ophthalmic Solutions Pharmaceutical Solutions Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |