Treatment of Tuberculosis Multidrug Resistance Treatment of Tuberculosis Multidrug Resistance

• Conditions: Multi-drug Resistant Tuberculosis

• Registration Number: NCT03057756
• Lead Sponsor: Centre de Recherche Médicale de Lambaréné

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 Timeline

• Study Start: 2015-09-11
• Study First Submitted: 2017-02-13
• Study First Submitted QC: 2017-02-15
• Study First Posted: 2017-02-20
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-27
• Primary Completion: 2023-04-04
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cure rate post treatment	Six months post treatment	Proportion of participants alive and presented with negative sputum culture for TB and with the absence of clinical, X-Ray and biological disorders related to TB

Secondary Outcome Measures

Name	Time	Method
TB-culture	4 months after start of the treatment	First TB culture negative time
Regimen tolorability	Throughout treatment period (9months)	treatment, safety through clinical and biological assessment
Adverse events	duration of participant in the study (15months)	solicited and unsolicited adverse events

Trial Locations

Locations (1)

Centre de Recherches Médicales de Lambaréné; 🇬🇦 Lambarene, Please Select, Gabon