A New Treatment for Primary Smear-positive Pulmonary Tuberculosis With Interleukin-2
NCT ID: NCT04766307
Last Updated: 2021-02-23
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
1100 participants
INTERVENTIONAL
2016-07-20
2021-12-31
Brief Summary
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Detailed Description
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2. Population:Initial smear positive pulmonary tuberculosis patients who fulfill the inclusion and exclusion criteria.
3. 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).
4. 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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experimental group
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).
Interleukin-2
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.
Control regimen group
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).
Interleukin-2
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.
Interventions
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Interleukin-2
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Is aged 18-65 years.
3. Chest X-ray showed that there were active tuberculosis foci in the lungs with one of the following cases: (1) sputum specimens (or sputum and bronchial lavage fluid) were 2+ once or 1+ twice ; (2) sputum smear positive and sputum X-pert positive.
4. Newly diagnosed cases receiving anti-TB treatment for less than one month.
5. No other immune preparations （such as: thymosin，IFN-y，BCG-PSN，Mycobacterium vaccae，Utilins，lentinan ）were used in the past 3 months.
6. the urine analysis of Women of childbearing age are negative and agree to use the efficient contraception during the study period.
Exclusion Criteria
2. There are serious complications or impaired renal function (serum creatinine is 1.5 times higher than the normal limit) or impaired liver function (ALT or AST levels are 3 times higher than the normal limit); hemoglobin is less than 7.0g/dl. Platelets less than 50x109/L.
3. Complication with Diabetic.
4. The screening diagnosis was isoniazid resistance or rifampin resistance
5. There are serious cardiovascular diseases, such as heart failure, hypertension, arrhythmia or post myocardial infarction state.
6. Is known to be pregnant or breast-feeding.
7. Karnofsky score is less than 50%.
8. Is taking any clinical trial in the past 3 months.
9. Is critically ill, and in the judgment of the investigator, not fit for the study or unlikely to complete the full course of study.
10. HIV is positive or AIDS patients.
11. Has Non tuberculous mycobacterial lung disease.
12. Merge with extra pulmonary tuberculosis.
18 Years
65 Years
ALL
No
Sponsors
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Beijing Chest Hospital
OTHER
Responsible Party
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Chu naihu
Director,TB Department
Principal Investigators
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Naihui Chu, PhD
Role: PRINCIPAL_INVESTIGATOR
Beijing Chest Hospital
Locations
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the Second hospital of Fuyang
Fuyang, Anhui, China
Fuzhou Chest Hospital
Fuzhou, Fujian, China
Shenzhen third people's Hospital
Shenzhen, Guangzhou, China
Guiyang Public Health Treatment Center
Guiyang, Guizhou, China
The Infectious Hospital of Handan
Handan, Hebei, China
Hebei Chest Hospital
Shijiazhuang, Hebei, China
Jiamusi Insititute For Tuberculosis Control
Jiamusi, Heilongjiang, China
The Infectious Hospital of mudanjiang
Mudanjiang, Heilongjiang, China
Zhengzhou Sixth People's Hospital
Zhengzhou, Henan, China
the central hospital of Changsha
Changsha, Hunan, China
the people's hospital of Jiangsu province
Nanjing, Jiangsu, China
Jiangxi Chest Hospital
Nanchang, Jiangxi, China
Dalian Tuberculosis Hospital
Dalian, Liaoning, China
Qingdao Chest Hospital
Qingdao, Shandong, China
Taiyuan Fourth People's Hospital
Taiyuan, Shanxi, China
Xian Chest Hospital
Xi’an, Shanxi, China
Countries
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Central Contacts
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Facility Contacts
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haiqing Liu
Role: primary
xiaohong Chen
Role: primary
qunyi Deng
Role: primary
jing Chen
Role: primary
chunyan Zhang
Role: primary
chao Qiu
Role: primary
lixiang Chu
Role: primary
yu Chen
Role: primary
chunxiang Li
Role: primary
hong Wang
Role: primary
aihua Deng
Role: primary
Qing Ji
Role: primary
yufeng Liu
Role: primary
Role: backup
quanhong Wang
Role: primary
liyun Dang
Role: primary
Other Identifiers
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2015ZX10003001-002
Identifier Type: -
Identifier Source: org_study_id
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