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A New Treatment for Primary Smear-positive Pulmonary Tuberculosis With Interleukin-2

A New Treatment for Primary Smear-positive Pulmonary Tuberculosis With Interleukin-2

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-17013878
Enrollment
Unknown
Registered
2017-12-12
Start date
2016-07-20
Completion date
Unknown
Last updated
2017-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

Interventions

experimental group:Interleukin 2

Sponsors

Beijing Chest Hospital affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. To be 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); 2. 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: thymosinIFN-yBCG-PSNMycobacterium vaccaeUtilinslentinan )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

Exclusion criteria: 1. Has a known allergy to any drug of treatment regimens; 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 50x10^9/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. Attending any clinical trial in the past 3 months; 9. with 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.

Design outcomes

Primary

MeasureTime frame
time to conversion;the rate of conversion at the end of the course of treatment;

Secondary

MeasureTime frame
adverse reactions;Recurrence rate;the rate of Treatment failure;

Countries

China

Contacts

Public ContactChu Naihui

Beijing Chest Hospital affiliated to Capital Medical University

dongchu1994@sina.com+86 13611326573

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026