Multidrug Resistant Tuberculosis Clinical Trial
Official title:
Effectiveness of a Simplified Short Regimen for Multidrug Resistant Tuberculosis Treatment in Karakalpakstan, Uzbekistan
Multidrug resistant tuberculosis (MDR TB) is a growing problem and few people have access to
adequate diagnosis and treatment. The current recommended treatment regimen for MDR TB has a
minimum of 20 months duration with high toxicity. Scale up of MDR TB treatment is associated
with high default rates, and experience in the Medecins Sans Frontieres (MSF) programme in
Uzbekistan shows that the current standard treatment greatly limits the ability to scale up
to meet the high rates of MDR TB in the region.
Evidence from Bangladesh in 2010 showed that a 9-month short-course regimen could achieve a
relapse-free cure rate of 88%. Several countries in West Africa started implementing similar
regimens with similar outcomes. Evidence of effectiveness of this shortened regimen among
regions with high second line drug use and resistance is still limited.
The investigators propose an observational study under programmatic conditions to evaluate
the effectiveness of a shortened course MDR TB regimen in the high MDR/extensively drug
resistant (XDR) TB prevalence and high second-line drug resistance setting of
Karakalpakstan, Uzbekistan.
A prospective observational study has been designed. The study regimen is composed of an
intensive phase of at least 4 months duration of Pyrazinamide (Z) + Ethambutol (E) +
Isoniazid (H) + Moxifloxacin (Mfx) + Capreomycin (or Kanamycin/Amikacin) (Cm/Km/Am) +
Prothionamide (Pto) + Clofazimine (Cfz) and a continuation phase of oral drugs
Z-E-Mfx-Pto-Cfz. Patients will be followed up until the end of treatment and during 12
months after treatment completion in order to evaluate the rate of relapse.
Data will be recorded in patient's clinical files and electronic databases and analyzed with
Stata 11.0.
This study is a result of ongoing collaboration of MSF with the Ministry of Health in
Uzbekistan; results will be shared with the national health authorities, World Health
Organization and the rest of the scientific community and aim to influence and improve
treatment and care of patients with MDR TB.
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Observational Model: Cohort, Time Perspective: Prospective
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