Reinfection Pulmonary Tuberculosis Clinical Trial
Official title:
New Super-short Course Regimen for Retreatment Pulmonary Tuberculosis
Multi-center, prospective study is performed to investigate the efficacy of new short-course
regimen for retreatment pulmonary tuberculosis patients.
To obtain optimized short-course regimen, decrease treatment cost and improve success rate.
China is the country with the second highest Tuberculosis (TB) burden in the world. Most of
the retreatment TB patients may develop multi-drug resistant. The resistant rate of any of
the anti-TB drug is 35.9%, and the multi-drug resistant rate is 15.4%. Retreatment TB
becomes one of the factors which inhibit the decrease of morbidity and mortality of TB. It
is also a tuff work in TB control. At present the standardized regimen for retreatment TB is
2SHREZ/6HRE or 3HREZ/6HRE. The drugs in the regimen are all first-line anti-TB drugs which
are unsuitable for the high drug resistance prevalence, because the cure rate of this
regimen is low and the adverse reaction is severe.
Our study is a national multi-center, prospective trail to investigate the efficacy of a new
super-short regimen for retreatment TB patients. The new regimen consists of 5 drugs lasting
5 months. The cure rate and success rate of the new regimen is compared with standardized
regimen usually 8-9 months in order to obtain the optimized regimen.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment