Treatment of Tuberculosis Multidrug Resistance Treatment of Tuberculosis Multidrug Resistance

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Multi-drug Resistant Tuberculosis

Intervention / Treatment
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* Combination Product: Km+ Mfx+ Pto + H + Cfz +E+Z


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TB-MR patients<br>Patients older than 15 years old receiving Km+ Mfx+ Pto + H + Cfz +E+Z | Combination Product: Km+ Mfx+ Pto + H + Cfz +E+Z<br>* Second generation of anti tuberculosis Kanamycine, Moxifloxacine,Prothionamide, isoniazide,Clofazimine, Ethambutol,Pyrazinamide<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cure rate 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 | Six months post treatment | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multi-drug Resistant Tuberculosis, short course regimen protocol