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

History of Changes

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:

MedlinePlus related topics: Tuberculosis

Drug Information available for: Gatifloxacin

Genetic and Rare Diseases Information Center resources: Tuberculosis

U.S. FDA Resources

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 (Adult)
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Merle CS, Fielding K, Sow OB, Gninafon M, Lo MB, Mthiyane T, Odhiambo J, Amukoye E, Bah B, Kassa F, N'Diaye A, Rustomjee R, de Jong BC, Horton J, Perronne C, Sismanidis C, Lapujade O, Olliaro PL, Lienhardt C; OFLOTUB/Gatifloxacin for Tuberculosis Project. A four-month gatifloxacin-containing regimen for treating tuberculosis. N Engl J Med. 2014 Oct 23;371(17):1588-98. doi: 10.1056/NEJMoa1315817. Erratum in: N Engl J Med. 2015 Apr 23;372(17):1677.

Smythe W, Merle CS, Rustomjee R, Gninafon M, Lo MB, Bah-Sow O, Olliaro PL, Lienhardt C, Horton J, Smith P, McIlleron H, Simonsson US. Evaluation of initial and steady-state gatifloxacin pharmacokinetics and dose in pulmonary tuberculosis patients by using monte carlo simulations. Antimicrob Agents Chemother. 2013 Sep;57(9):4164-71. doi: 10.1128/AAC.00479-13. Epub 2013 Jun 17.

Merle CS, Sismanidis C, Sow OB, Gninafon M, Horton J, Lapujade O, Lo MB, Mitchinson DA, Perronne C, Portaels F, Odhiambo J, Olliaro P, Rustomjee R, Lienhardt C, Fielding K. A pivotal registration phase III, multicenter, randomized tuberculosis controlled trial: design issues and lessons learnt from the Gatifloxacin for TB (OFLOTUB) project. Trials. 2012 May 18;13:61. doi: 10.1186/1745-6215-13-61.


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-Bacterial Agents Anti-Infective Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents

ClinicalTrials.gov processed this record on September 23, 2016

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