NCT03057756

Treatment of Tuberculosis Multidrug Resistance Treatment of Tuberculosis Multidrug Resistance

Nine Months' Short Course Regimen Protocol for the Treatment of Multidrug Resistance-tuberculosis (MDR-TB) Patients in Gabon

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 23 (actual)
• Sponsor: Centre de Recherche Médicale de Lambaréné · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Accepted

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.

Conditions

• Multi-drug Resistant Tuberculosis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Km+ Mfx+ Pto + H + Cfz +E+Z	Second generation of anti tuberculosis Kanamycine, Moxifloxacine,Prothionamide, isoniazide,Clofazimine, Ethambutol,Pyrazinamide

Timeline

• Start date: 2015-09-11
• Primary completion: 2023-04-04
• Completion: 2023-05-01
• First posted: 2017-02-20
• Last updated: 2026-03-17

Locations

1 site across 1 country: Gabon