Reinfection Pulmonary Tuberculosis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGIsoniazid Aminosalicylate Tablets
a regimen consists of 5 anti-TB drugs (Isoniazid Aminosalicylate Tablets+pyrazinamide tablets+ethambutol tablets+rifabutin capsules+moxifloxacin tablets)to treat retreatment pulmonary tuberculosis patients. The total treatment course is 5 months.
DRUGStreptomycin injectable
standardized regimen 2 months of streptomycin injectable + isoniazid tablets + ethambutol tablets + rifampicin capsules + pyrazinamide tablets and 6 months of isoniazid tablets + ethambutol tablets + rifampicin capsules or 3 months of isoniazid tablets + ethambutol tablets + rifampicin capsules + pyrazinamide tablets and 6 months of isoniazid tablets + ethambutol tablets + rifampicin capsules to treat Arm B patients as a control to arm A.The treatment course is 8-9 months.
Sponsors
Shanghai Center for Disease Control and Prevention
Jiangsu Province Centers for Disease Control and Prevention
Zhejiang University
Centers for Disease Control and Prevention
Shanghai Pulmonary Hospital, Shanghai, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Sputum confirmed diagnosis of retreatment pulmonary tuberculosis * Must be able to swallow tablets * Must be able to sign written informed consent form
Exclusion criteria
* Extra-pulmonary tuberculosis * Diabetes * Allergy to any of the medications in the regimen or pregnancy * Liver disease * Renal disease * Metabolic disease * Immune system disease * Hematological disease * Nervous system and mental disease * Endocrine disease * Malignant disease * Receiving immunosuppressive therapy * HIV/AIDS * Alcohol addiction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| success rate | for arm A,the point is 5 month after treatment. For arm B,the time point is at the end of the 8 or 9 month's treatment. |
Secondary
| Measure | Time frame |
|---|---|
| adverse reaction rate | for arm A,the point is 5 month after treatment. For arm B,the time point is at the end of the 8 or 9 month's treatment. |
Countries
China
Contacts
Primary ContactQing Zhang, M.D
Backup ContactWei Sha, M.D
Outcome results
None listed