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

Condition(s) targeted: Tuberculosis

Intervention: Gatifloxacin combined regimen (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Institut de Recherche pour le Developpement

Official(s) and/or principal investigator(s):
Christian Lienhardt, MD, Study Director, Affiliation: Institut de Recherche pour le Developpement

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,

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Efficacy: Percentage of relapses by 24 months following treatment cure

Safety: Percentage of adverse events

Secondary outcome:

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

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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Programme National de Lutte contre la Tuberculose, Cotonou, Benin; Recruiting
Martin Gninafon, MD, Phone: + 229 33 15 33, Email: pnt@intnet.bj
Martin Gninafon, MD, Principal Investigator

Service Pneumo-Phtisiologie, CHU Ignace Deen, Conakry, Guinea; Recruiting
Oumou Y Sow, MD, Phone: +224 41 20 58, Email: prsow@kassa.sotelgui.net.gn
Oumou Sow, MD, Principal Investigator

Kenya Medical Research Institute, Nairobi, Kenya; Recruiting
Joseph Odhiambo, MD, Phone: + 254 02 71 30 08, Email: jodhiambo@nairobi.mimcom.net
Joseph Odhiambo, MD, Principal Investigator

Programme National de Lutte contre la Tuberculose, Dakar, Senegal; Recruiting
Cheikh Seck, MD, Phone: + 221 824.90.09, Email: cheikbaf@yahoo.fr
Cheikh Seck, MD, Principal Investigator

Medical Research Council, Durban, KwaZulu, South Africa; Recruiting
Roxana Rustomjee, MD, Phone: +27 31 207 16 75, Email: Roxana.rustomjee@mrc.ac.za
Roxana Rustomjee, MD, Principal Investigator

Starting date: January 2005
Last updated: September 20, 2005