A Controlled Trial of a 4-Month Quinolone-Containing Regimen for the Treatment of Pulmonary Tuberculosis
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
1 other identifier
interventional
2,070
5 countries
5
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,
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2005
Typical duration for phase_3
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 16, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedSeptember 22, 2005
September 1, 2005
September 16, 2005
September 20, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Efficacy: Percentage of relapses by 24 months following treatment cure
Safety: Percentage of adverse events
Secondary Outcomes (5)
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
Interventions
Eligibility Criteria
You may qualify if:
- Male or female patients
- Aged 18 to 65 years
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut de Recherche pour le Developpementlead
- World Health Organizationcollaborator
- European Commissioncollaborator
Study Sites (5)
Programme National de Lutte contre la Tuberculose
Cotonou, Benin
Service Pneumo-Phtisiologie, CHU Ignace Deen
Conakry, Guinea
Kenya Medical Research Institute
Nairobi, Kenya
Programme National de Lutte contre la Tuberculose
Dakar, Senegal
Medical Research Council
Durban, KwaZulu, South Africa
Related Publications (5)
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.
PMID: 30496458DERIVEDOlliaro 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.
PMID: 28438924DERIVEDMerle 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.
PMID: 25337748DERIVEDSmythe 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.
PMID: 23774436DERIVEDMerle 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.
PMID: 22607233DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Christian Lienhardt, MD
Institut de Recherche pour le Developpement
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
September 16, 2005
First Posted
September 22, 2005
Study Start
January 1, 2005
Study Completion
December 1, 2008
Last Updated
September 22, 2005
Record last verified: 2005-09