TB Research

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

Naihui Chu, PhD

Abstract

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.

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.

MeSH terms

  • Tuberculosis, Pulmonary