NCT04766307

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

A Randomized Multicenter Clinical Trial of a New Treatment for Primary Smear- Positive Pulmonary Tuberculosis With Interleukin-2

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,100 (estimated)
• Sponsor: Beijing Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 tuberculosis.

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 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

• Tuberculosis, Pulmonary

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2016-07-20
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2021-02-23
• Last updated: 2021-02-23

Locations

16 sites across 1 country: China