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.
Status | Recruiting |
Enrollment | 864 |
Est. completion date | December 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Shanghai Pulmonary Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Pulmonary Hospital, Shanghai, China | Centers for Disease Control and Prevention, Jiangsu Province Centers for Disease Control and Prevention, Shanghai Center for Disease Control and Prevention, Zhejiang University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | No | |
Secondary | 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. | Yes |