Multi-drug Resistant Tuberculosis
Conditions
Keywords
Multi-drug Resistant Tuberculosis, short course regimen protocol
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.
Interventions
COMBINATION_PRODUCTKm+ Mfx+ Pto + H + Cfz +E+Z
Second generation of anti tuberculosis Kanamycine, Moxifloxacine,Prothionamide, isoniazide,Clofazimine, Ethambutol,Pyrazinamide
Sponsors
Centre de Recherche Médicale de Lambaréné
Institute of Tropical Medicine, University of Tuebingen
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Gabon
Contacts
PRINCIPAL_INVESTIGATORAyola A Adegnika, MD, PhD
Centre de Recherches Médicales de Lambaréné
Outcome results
None listed