Research on New Regimens for Retreatment Pulmonary Tuberculosis
NCT ID: NCT02331823
Last Updated: 2015-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
864 participants
INTERVENTIONAL
2013-06-30
2016-12-31
Brief Summary
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To obtain optimized short-course regimen, decrease treatment cost and improve success rate.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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arm A: super-short retreatment regimen
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
Isoniazid 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.
arm B:standardized retreatment regimen
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
Streptomycin 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.
Interventions
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Isoniazid 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.
Streptomycin 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must be able to swallow tablets
* Must be able to sign written informed consent form
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Shanghai Center for Disease Control and Prevention
OTHER
Jiangsu Province Centers for Disease Control and Prevention
NETWORK
Zhejiang University
OTHER
Centers for Disease Control and Prevention
FED
Shanghai Pulmonary Hospital, Shanghai, China
OTHER
Responsible Party
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Qing Zhang
Chief physician
Principal Investigators
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Heping Xiao, M.D
Role: PRINCIPAL_INVESTIGATOR
Shanghai Pulmonary Hospital,China
Locations
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Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Yan L, Kan X, Zhu L, Xu K, Yin J, Jie L, Li Y, Yue J, Cui W, Du J, Wang L, Tan S, Jiang X, Zeng Z, Xu S, Wang L, Chen Y, He W, Gao X, Bai D, Zhao C, Yan X, Zhu Y, Fan Y, Xie L, Deng A, Zhang Q, Xiao H. Short-course Regimen for Subsequent Treatment of Pulmonary Tuberculosis: A Prospective, Randomized, Controlled Multicenter Clinical Trial in China. Clin Ther. 2018 Mar;40(3):440-449. doi: 10.1016/j.clinthera.2018.01.013. Epub 2018 Mar 6.
Other Identifiers
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2013ZX10003009
Identifier Type: -
Identifier Source: org_study_id
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