Research on New Regimens for Retreatment Pulmonary Tuberculosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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New Super-short Course Regimen for Retreatment Pulmonary Tuberculosis

Conditions
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Reinfection Pulmonary Tuberculosis

Intervention / Treatment
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* Drug: Isoniazid Aminosalicylate Tablets
* Drug: Streptomycin injectable


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: arm A: super-short retreatment regimen<br>A regimen of 5 drugs is to be administered. Isoniazid Aminosalicylate Tablets,0.3g tid po for 5 mon moxifloxacin tab, 0.4g qd po for 5 mon rifabutin capsule,0.3g qd po for 5 mon ethambutol tab, 0.75g qd po for 5 mon pyrazinamide tab, 0.5g tid po for 5 mon | Drug: Isoniazid Aminosalicylate Tablets<br>* 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.<br>* Other names: moxifloxacin tablets;|
| Active Comparator: arm B:standardized retreatment regimen<br>8-9 months of standardized regimen is to be administered. regimen 1.2SHREZ/6HRE streptomycin injectable,0.75g qd intramuscular for 2 mon isoniazid tab,0.3g qd po for 8 mon rifampicin capsule,0.45-0.6g po for 8 mon ethambutol tab, 0.75g qd po for 8 mon pyrazinamide tab, 0.5g tid po for 2 mon or regimen 2.3HREZ/6HRE isoniazid tab,0.3g qd po for 9 mon rifampicin capsule,0.45-0.6g po for 9 mon ethambutol tab, 0.75g qd po for 9 mon pyrazinamide tab, 0.5g tid po for 3 mon | Drug: Streptomycin injectable<br>* 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.<br>* Other names: pyrazinamide tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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. |