Treatment of Tuberculosis Multidrug Resistance Treatment of Tuberculosis Multidrug Resistance (TB-MR)

Centre de Recherche Médicale de Lambaréné

Status: Unknown

Conditions: Multi-drug Resistant Tuberculosis

Treatments: Combination Product: Km+ Mfx+ Pto + H + Cfz +E+Z

Study type: Observational

Funder types: Other

Identifiers

NCT03057756

TB-MR 001/2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged 15 years and above
• Never been treated with second line anti-TB drugs for more than one month,
• Give written consent to participate
• Agree to be hospitalised for at least four months in specialised healthcare
• Willing to adhere to ambulatory directly observed treatment by a healthcare worker;

Exclusion criteria

• Pregnant during inclusion process
• Presented with altered clinical status condition as judged by the clinician
• Knowing of history of hypersensitivity reaction to any of the drugs to be used
• Baseline ECG does not show a QT space superior to 500ms
• Refusal to participate into study.

Trial design

23 participants in 1 patient group

TB-MR patients

Description:

Patients older than 15 years old receiving Km+ Mfx+ Pto + H + Cfz +E+Z

Treatment:

Combination Product: Km+ Mfx+ Pto + H + Cfz +E+Z