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

Primary Purpose

Tuberculosis

Status

Unknown status

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Gatifloxacin combined regimen

About this trial

This is an interventional treatment trial for Tuberculosis focused on measuring Tuberculosis, Treatment, Quinolone, Short course chemotherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Programme National de Lutte contre la TuberculoseRecruiting
Service Pneumo-Phtisiologie, CHU Ignace DeenRecruiting
Kenya Medical Research InstituteRecruiting
Programme National de Lutte contre la TuberculoseRecruiting
Medical Research CouncilRecruiting

Outcomes

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

Full Information

NCT ID

NCT00216385

First Posted

September 16, 2005

Last Updated

September 20, 2005

Sponsor

Institut de Recherche pour le Developpement

Collaborators

World Health Organization, European Commission

1. Study Identification

Unique Protocol Identification Number

NCT00216385

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Unknown status

Study Start Date

January 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2008 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Institut de Recherche pour le Developpement

Collaborators

World Health Organization, European Commission

4. Oversight

5. Study Description

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,

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tuberculosis

Keywords

Tuberculosis, Treatment, Quinolone, Short course chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2070 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Gatifloxacin combined regimen

Primary Outcome Measure Information:

Title

Efficacy: Percentage of relapses by 24 months following treatment cure

Title

Safety: Percentage of adverse events

Secondary Outcome Measure Information:

Title

Efficacy: Time to relapse

Title

Efficacy: Percentage of smear and culture conversion at 8 weeks

Title

Efficacy: Percentage of patient cured at the end of treatment

Title

Efficacy: Time to a composite "unsatisfactory" endpoint

Title

Safety outcome: Distribution of type and grading of adverse events

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian Lienhardt, MD

Organizational Affiliation

Institut de Recherche pour le Developpement

Official's Role

Study Director

Facility Information:

Facility Name

Programme National de Lutte contre la Tuberculose

City

Cotonou

Country

Benin

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Martin Gninafon, MD

Phone

+ 229 33 15 33

pnt@intnet.bj

First Name & Middle Initial & Last Name & Degree

Martin Gninafon, MD

Facility Name

Service Pneumo-Phtisiologie, CHU Ignace Deen

City

Conakry

Country

Guinea

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Oumou Y Sow, MD

Phone

+224 41 20 58

prsow@kassa.sotelgui.net.gn

First Name & Middle Initial & Last Name & Degree

Oumou Sow, MD

Facility Name

Kenya Medical Research Institute

City

Nairobi

Country

Kenya

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joseph Odhiambo, MD

Phone

+ 254 02 71 30 08

jodhiambo@nairobi.mimcom.net

First Name & Middle Initial & Last Name & Degree

Joseph Odhiambo, MD

Facility Name

Programme National de Lutte contre la Tuberculose

City

Dakar

Country

Senegal

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cheikh Seck, MD

Phone

+ 221 824.90.09

cheikbaf@yahoo.fr

First Name & Middle Initial & Last Name & Degree

Cheikh Seck, MD

Facility Name

Medical Research Council

City

Durban

State/Province

KwaZulu

Country

South Africa

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Roxana Rustomjee, MD

Phone

+27 31 207 16 75

Roxana.rustomjee@mrc.ac.za

First Name & Middle Initial & Last Name & Degree

Roxana Rustomjee, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

30496458

Citation

Pasipanodya JG, Smythe W, Merle CS, Olliaro PL, Deshpande D, Magombedze G, McIlleron H, Gumbo T. Artificial intelligence-derived 3-Way Concentration-dependent Antagonism of Gatifloxacin, Pyrazinamide, and Rifampicin During Treatment of Pulmonary Tuberculosis. Clin Infect Dis. 2018 Nov 28;67(suppl_3):S284-S292. doi: 10.1093/cid/ciy610.

Results Reference

derived

PubMed Identifier

28438924

Citation

Olliaro PL, Merle C, Mthiyane T, Bah B, Kassa F, Amukoye E, N Diaye A, Perronne C, Lienhardt C, McIlleron H, Fielding K. Effects on the QT Interval of a Gatifloxacin-Containing Regimen versus Standard Treatment of Pulmonary Tuberculosis. Antimicrob Agents Chemother. 2017 Jun 27;61(7):e01834-16. doi: 10.1128/AAC.01834-16. Print 2017 Jul.

Results Reference

derived

PubMed Identifier

25337748

Citation

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.

Results Reference

derived

PubMed Identifier

23774436

Citation

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.

Results Reference

derived

PubMed Identifier

22607233

Citation

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.

Results Reference

derived

Learn more about this trial

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

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