Who is sponsoring NCT00216385?

NCT00216385 is sponsored by Institut de Recherche pour le Developpement.

What condition does NCT00216385 study?

NCT00216385 studies Tuberculosis.

What drugs are being tested in NCT00216385?

Interventions: Gatifloxacin combined regimen.

What is the status of NCT00216385?

NCT00216385 is currently UNKNOWN.

Last reviewed 2005-09-20 · How we verify

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

NCT00216385 Phase 3 UNKNOWN

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,

Details

Lead sponsor	Institut de Recherche pour le Developpement
Phase	Phase 3
Status	UNKNOWN
Enrolment	2070
Start date	2005-01
Completion	2008-12

Conditions

Tuberculosis

Interventions

Gatifloxacin combined regimen

Primary outcomes

Efficacy: Percentage of relapses by 24 months following treatment cure
Safety: Percentage of adverse events

Countries

Benin, Guinea, Kenya, Senegal, South Africa