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TuberculosisPhase 3NCT00216385

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

A Phase 3 study testing Gatifloxacin combined regimen in people with Tuberculosis, run by Institut de Recherche pour le Developpement at 5 sites in 5 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Tuberculosis
What is being tested?
Gatifloxacin combined regimen
How many people
2,070 participants
Where
5 sitesin 5 countries
Study dates
Jan 2005to Dec 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

5 sites in 5 countries.

5 sites in 5 countries

Benin1 site, 1 recruiting

  • Programme National de Lutte contre la Tuberculose

    Cotonou

    Martin Gninafon, MD, + 229 33 15 33, pnt@intnet.bj

    Martin Gninafon, MD

    Recruiting

Other trials in Benin

Guinea1 site, 1 recruiting

  • Service Pneumo-Phtisiologie, CHU Ignace Deen

    Conakry

    Oumou Y Sow, MD, +224 41 20 58, prsow@kassa.sotelgui.net.gn

    Oumou Sow, MD

    Recruiting

Other trials in Guinea

Kenya1 site, 1 recruiting

  • Kenya Medical Research Institute

    Nairobi

    Joseph Odhiambo, MD, + 254 02 71 30 08, jodhiambo@nairobi.mimcom.net

    Joseph Odhiambo, MD

    Recruiting

Other trials in Kenya

Senegal1 site, 1 recruiting

  • Programme National de Lutte contre la Tuberculose

    Dakar

    Cheikh Seck, MD, + 221 824.90.09, cheikbaf@yahoo.fr

    Cheikh Seck, MD

    Recruiting

Other trials in Senegal

South Africa1 site, 1 recruiting

  • Medical Research Council

    Durban, KwaZulu

    Roxana Rustomjee, MD, +27 31 207 16 75, Roxana.rustomjee@mrc.ac.za

    Roxana Rustomjee, MD

    Recruiting

Other trials in South Africa

About this 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

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,

Read the 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.

Conditions
Tuberculosis
Being tested
Gatifloxacin combined regimen
Keywords
Tuberculosis, Treatment, Quinolone, Short course chemotherapy
Medical subject headings
Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gatifloxacin combined regimenDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy: Percentage of relapses by 24 months following treatment cure

  2. Safety: Percentage of adverse events

Secondary outcomes (5)

  1. Efficacy: Time to relapse

  2. Efficacy: Percentage of smear and culture conversion at 8 weeks

  3. Efficacy: Percentage of patient cured at the end of treatment

  4. Efficacy: Time to a composite "unsatisfactory" endpoint

  5. Safety outcome: Distribution of type and grading of adverse events

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startJan 2005
  3. Study completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,070 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00216385
Sponsor's protocol ID
ICA4-CT 2002-10057
Status last verified
Sep 2005
First submitted
16 Sep 2005
Last updated
22 Sep 2005
Results posted
No

Publications

  • 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.

    PubMed 30496458

  • 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.

    PubMed 28438924

  • 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.

    PubMed 25337748

  • 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.

    PubMed 23774436

  • 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.

    PubMed 22607233

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gatifloxacin combined regimen in people with Tuberculosis, run by Institut de Recherche pour le Developpement at 5 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Benin, Guinea, Kenya, Senegal, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy: Percentage of relapses by 24 months following treatment cure. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00216385, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2005.

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