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

French Public Scientific and Technological Institution (EPST)

Status and phase

Unknown

Phase 3

Conditions

Tuberculosis

Treatments

Drug: Gatifloxacin combined regimen

Study type

Interventional

Funder types

Other

Identifiers

NCT00216385

ICA4-CT 2002-10057

Details and patient eligibility

About

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,

Full 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.

Sex

All

Ages

18 to 65 years old

Volunteers

No 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.