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

Conditions

Tuberculosis

Keywords

Tuberculosis, Treatment, Quinolone, Short course chemotherapy

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.

Jotam G. Pasipanodya, Wynand Smythe, Corinne Merle, Piero Olliaro, Devyani Deshpande et al. (8 authors)

Clinical Infectious Diseases2018-07-2717 citations

10.1093/cid/ciy610

Effects on the QT Interval of a Gatifloxacin-Containing Regimen versus Standard Treatment of Pulmonary Tuberculosis

Piero Olliaro, Corinne Merle, Thuli Mthiyane, Boubacar Bah, Ferdinand Kassa et al. (11 authors)

Antimicrobial Agents and Chemotherapy2017-04-2521 citations

10.1128/aac.01834-16

A Four-Month Gatifloxacin-Containing Regimen for Treating Tuberculosis

Corinne Merle, Katherine Fielding, Omou Bah Sow, M. Gninafon, Mame Bocar Lo et al. (19 authors)

New England Journal of Medicine2014-10-22399 citations

10.1056/nejmoa1315817

Randomized Clinical Trial of Thrice-Weekly 4-Month Moxifloxacin or Gatifloxacin Containing Regimens in the Treatment of New Sputum Positive Pulmonary Tuberculosis Patients

M S Jawahar, Vaithilingam V. Banurekha, Chinnampedu N. Paramasivan, Fathima Rahman, Rajeswari Ramachandran et al. (25 authors)

PLoS ONE2013-07-0396 citations

10.1371/journal.pone.0067030

Evaluation of Initial and Steady-State Gatifloxacin Pharmacokinetics and Dose in Pulmonary Tuberculosis Patients by Using Monte Carlo Simulations

Wynand Smythe, Corinne Merle, Roxana Rustomjee, M. Gninafon, Mame Bocar Lo et al. (12 authors)

Antimicrobial Agents and Chemotherapy2013-06-1815 citations

10.1128/aac.00479-13

A pivotal registration phase III, multicenter, randomized tuberculosis controlled trial: design issues and lessons learnt from the Gatifloxacin for TB (OFLOTUB) project.

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.

2012-05-1825 citations

10.1186/1745-6215-13-61

Interventions

DRUGGatifloxacin combined regimen

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame
Efficacy: Percentage of relapses by 24 months following treatment cure	—
Safety: Percentage of adverse events	—

Secondary

Measure	Time frame
Efficacy: Percentage of patient cured at the end of treatment	—
Efficacy: Time to relapse	—
Safety outcome: Distribution of type and grading of adverse events	—
Efficacy: Time to a composite unsatisfactory endpoint	—
Efficacy: Percentage of smear and culture conversion at 8 weeks	—

Countries

Benin, Guinea, Kenya, Senegal, South Africa

Outcome results

None listed