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The purpose of the study is to compare the efficacy and safety of standard chemotherapy regimen 2HRZE/4HR plus IL-2 and standard regimen 2HRZE/4HR for newly diagnosed smear positive pulmonary tuberculosis.
Design:The study is a multi-center, randomized, controlled, open clinical trial.
Population:Initial smear positive pulmonary tuberculosis patients who fulfill the inclusion and exclusion criteria.
Investigational regimens:
Experimental group regimen:2HRZE/4HR+Interleukin-2 (500000 units daily, subcutaneous injection in the first month) The control group regimen: 2HRZE/4HR Dosage: isoniazid 300mg(given once daily),rifampin 450mg(less than 50kg,given once daily) or 600mg(more than 50kg,given once daily),pyrazinamide 1500mg(less than 50kg,given once daily) or 30mg/kg(more than 50kg,given once daily),ethambutol 750mg(less than 50kg,given once daily) or 1000mg(more than 50kg,given once daily).
Primary and Secondary outcome measures:
primary efficacy outcome measures:(a)Negative conversion rate of sputum bacteria. (b)Sputum smear conversion proportion at the treatment completion .
secondary efficacy outcome measure:Recurrence rate after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | Experimental group regimen:2H(Isoniazid)R(Rifampicin)Z(Pyrazinamide)E(Ethambutol)/4HR+Interleukin-2 (500000 units daily, subcutaneous injection in the first month) Dosage: isoniazid 300mg(given once daily),rifampin 450mg(less than 50kg,given once daily) or 600mg(more than 50kg,given once daily),pyrazinamide 1500mg(less than 50kg,given once daily) or 30mg/kg(more than 50kg,given once daily),ethambutol 750mg(less than 50kg,given once daily) or 1000mg(more than 50kg,given once daily). |
|
| Control regimen group | Active Comparator | The control group regimen: 2H(Isoniazid)R(Rifampicin)Z(Pyrazinamide)E(Ethambutol)/4HR Dosage: isoniazid 300mg(given once daily),rifampin 450mg(less than 50kg,given once daily) or 600mg(more than 50kg,given once daily),pyrazinamide 1500mg(less than 50kg,given once daily) or 30mg/kg(more than 50kg,given once daily),ethambutol 750mg(less than 50kg,given once daily) or 1000mg(more than 50kg,given once daily). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interleukin-2 | Drug | Interleukin 2 (IL-2) is a pleiotropic cytokine that is produced after antigen activation and plays crucial roles in the immune response. IL-2 secreted by activated T cells is central to the development of an immune response to infection, promoting the differentiation and proliferation of lymphoid cells. This hydrophobic molecule and the various cytokines that it elicits regulates the behavior of T and B lymphocytes, monocytes/macrophages, natural killer (NK) cells, and neutrophils. IL-2 therapy regimens are expected to limit mycobacterial replication. Early clinical trials with IL-2 demonstrated that IL-2 immunotherapy may be useful in controlling infectious disease. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary study endpoint was the proportion of subjects who had converted their sputum cultures to negative at the end of treatment. | A cure was defined as who was smear- or culture-negative in the last month of treatment and on at least one previous occasion. Treatment completion was defined as patients who completed treatment but who does not have a negative sputum smear or culture result in the last month of treatment and on at least one previous occasion. Treatment failure was defined as patients whose sputum smear or culture is positive at 5 months or later during treatment. | two-month course intensive phase treatment, followed by a four-month consolidation phase treatment.Some TB patients with cavity should receive 9 total months (7 months of continuation therapy after the initial 2-month intensive phase). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Naihui Chu, PhD | Contact | dongchu1994@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Naihui Chu, PhD | Beijing Chest Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Second hospital of Fuyang | Recruiting | Fuyang | Anhui | 230000 | China |
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| ID | Term |
|---|---|
| D014397 | Tuberculosis, Pulmonary |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
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| ID | Term |
|---|---|
| D007376 | Interleukin-2 |
| ID | Term |
|---|---|
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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| Fuzhou Chest Hospital | Recruiting | Fuzhou | Fujian | 350000 | China |
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| Shenzhen third people's Hospital | Recruiting | Shenzhen | Guangzhou | 518000 | China |
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| Guiyang Public Health Treatment Center | Recruiting | Guiyang | Guizhou | 550000 | China |
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| The Infectious Hospital of Handan | Recruiting | Handan | Hebei | 056000 | China |
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| Hebei Chest Hospital | Recruiting | Shijiazhuang | Hebei | 050000 | China |
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| Jiamusi Insititute For Tuberculosis Control | Recruiting | Jiamusi | Heilongjiang | 154000 | China |
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| The Infectious Hospital of mudanjiang | Recruiting | Mudanjiang | Heilongjiang | 150000 | China |
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| Zhengzhou Sixth People's Hospital | Recruiting | Zhengzhou | Henan | 450000 | China |
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| the central hospital of Changsha | Recruiting | Changsha | Hunan | 410000 | China |
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| the people's hospital of Jiangsu province | Recruiting | Nanjing | Jiangsu | 210000 | China |
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| Jiangxi Chest Hospital | Recruiting | Nanchang | Jiangxi | 330000 | China |
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| Dalian Tuberculosis Hospital | Recruiting | Dalian | Liaoning | 110000 | China |
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| Qingdao Chest Hospital | Recruiting | Qingdao | Shandong | 266000 | China |
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| Taiyuan Fourth People's Hospital | Recruiting | Taiyuan | Shanxi | 030000 | China |
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| Xian Chest Hospital | Recruiting | Xi’an | Shanxi | 710000 | China |
|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |