Status:
UNKNOWN
A New Treatment for Primary Smear-positive Pulmonary Tuberculosis With Interleukin-2
Lead Sponsor:
Beijing Chest Hospital
Conditions:
Tuberculosis, Pulmonary
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
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 tubercul...
Detailed Description
1. Design:The study is a multi-center, randomized, controlled, open clinical trial. 2. Population:Initial smear positive pulmonary tuberculosis patients who fulfill the inclusion and exclusion criteri...
Eligibility Criteria
Inclusion
- Is willing and able to give informed consent to participate in the trial treatment and follow-up (signed or witnessed consent if the patient is illiterate).
- Is aged 18-65 years.
- 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.
- Newly diagnosed cases receiving anti-TB treatment for less than one month.
- No other immune preparations （such as: thymosin，IFN-y，BCG-PSN，Mycobacterium vaccae，Utilins，lentinan ）were used in the past 3 months.
- the urine analysis of Women of childbearing age are negative and agree to use the efficient contraception during the study period.
Exclusion
- Has a known allergy to any drug of treatment regimens.
- 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.
- Complication with Diabetic.
- The screening diagnosis was isoniazid resistance or rifampin resistance
- There are serious cardiovascular diseases, such as heart failure, hypertension, arrhythmia or post myocardial infarction state.
- Is known to be pregnant or breast-feeding.
- Karnofsky score is less than 50%.
- Is taking any clinical trial in the past 3 months.
- Is critically ill, and in the judgment of the investigator, not fit for the study or unlikely to complete the full course of study.
- HIV is positive or AIDS patients.
- Has Non tuberculous mycobacterial lung disease.
- Merge with extra pulmonary tuberculosis.
Key Trial Info
Start Date :
July 20 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
1100 Patients enrolled
Trial Details
Trial ID
NCT04766307
Start Date
July 20 2016
End Date
December 31 2021
Last Update
February 23 2021
Active Locations (16)
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1
the Second hospital of Fuyang
Fuyang, Anhui, China, 230000
2
Fuzhou Chest Hospital
Fuzhou, Fujian, China, 350000
3
Shenzhen third people's Hospital
Shenzhen, Guangzhou, China, 518000
4
Guiyang Public Health Treatment Center
Guiyang, Guizhou, China, 550000