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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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18 April 2017 |
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Main ID: |
ChiCTR-IOR-14005618 |
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Date of registration:
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2014-11-29 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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New Short-course Regimen for Retreatment Pulmonary Tuberculosis
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Scientific title:
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New Short-course Regimen for Retreatment Pulmonary Tuberculosis |
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Date of first enrolment:
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2013-07-29 |
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Target sample size:
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treatment group :648;control group:218; |
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Recruitment status: |
Completed |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=10009 |
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Study type:
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Interventional study |
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Study design:
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Randomized parallel controlled trial
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Phase:
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Other
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Countries of recruitment
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China
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Contacts
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Name:
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Zhang Qing
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Address:
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507 ZhengMin Road, Shanghai
200433
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Telephone:
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+86 13621682327 |
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Email:
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zhqi709851@sohu.com |
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Affiliation:
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Shanghai Pulmonary Hospital |
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Name:
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Xiao Heping
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Address:
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507 ZhengMin Road, Shanghai
200433
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Telephone:
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+86 18017721479 |
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Email:
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xiaoheping_sars@163.com |
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Affiliation:
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Shanghai Pulmonary Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Retreatment pulmonary tuberculosis with sputum smear positive;
2. The first time retreatment;
3. Aged 18-65 years old;
4. At enrollment the patients are capable to provide sputum for examination;
5. Normal liver and renal function, without diabetes;
6. Sign written informed consent form.
Exclusion criteria: 1. Pulmonary tuberculosis complicated by extra-pulmonary tuberculosis;
2. Allergy to any of the medications in the regimen;
3. Pregnancy or with any of the following: liver, renal, metabolic, immune system diseases, hematological diseases, nervous system diseases, mental diseases, endocrine diseases, tumor, receiving immunosuppressive therapy and HIV/AIDS;
4. Alcohol addiction;
5. With the disease unsuitable to participant in the trial;
6. Have been enrolled to another study at the time of recruitment;
7. Incompliance in the former study.
Age minimum:
18
Age maximum:
65
Gender:
Both
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Health Condition(s) or Problem(s) studied
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retreatment tuberculosis
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Intervention(s)
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treatment group :chemotherapy ;control group:chemotherapy ;
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Primary Outcome(s)
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cure rate;success rate;
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Source(s) of Monetary Support
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The central Treasury
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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