Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:11 PM
Study NCT ID:
NCT03057756
Status:
UNKNOWN
Last Update Posted:
2021-07-27
First Post:
2017-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Tuberculosis Multidrug Resistance Treatment of Tuberculosis Multidrug Resistance
Sponsor:
Centre de Recherche Médicale de Lambaréné
Organization:
Study Overview
Official Title:
Nine Months' Short Course Regimen Protocol for the Treatment of Multidrug Resistance-tuberculosis (MDR-TB) Patients in Gabon
Status:
UNKNOWN
Status Verified Date:
2021-07
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:
TB-MR
Brief Summary:
The principal objective is to evaluate a cure rate and number of adverse events of with confirmed multidrug-resistant tuberculosis patient treated with a 9months regimen.
Detailed Description:
Study participants will be followed up, under existing protocol derived from a study protocol developed by the "Union internationale contre les maladies respiratoires" and carried out already in 9 Africans countries. Participants will be hospitalised for at least four month, period which they will be given treatments, assessed for adverse events, monitored for TB-MR strains using culture techniques, at the monthly basis. If patients found with negative sputum culture at month four they will be dischrged from the hospital, and then treated four an additional five montns and then follow up, clinically and biologically for an additional six months before being declared as cured.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: