Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216385
Status:
UNKNOWN
Last Update Posted:
2005-09-22
First Post:
2005-09-16
Brief Title:
A Controlled Trial of a 4-Month Quinolone-Containing Regimen for the Treatment of Pulmonary Tuberculosis
Sponsor:
Institut de Recherche pour le Developpement
Organization:
Institut de Recherche pour le Developpement
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None