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

Beijing Chest Hospital1,100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,100

Conditions

Tuberculosis, Pulmonary

Interventions

Interleukin-2DRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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). 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: 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 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.

Locations (16)

the Second hospital of Fuyang

Fuyang, Anhui, China

RECRUITING

Fuzhou Chest Hospital

Fuzhou, Fujian, China

Outcomes

Primary Outcomes

The primary study endpoint was the proportion of subjects who had converted their sputum cultures to negative at the end of treatment.

A cure was defined as who was smear- or culture-negative in the last month of treatment and on at least one previous occasion. Treatment completion was defined as patients who completed treatment but who does not have a negative sputum smear or culture result in the last month of treatment and on at least one previous occasion. Treatment failure was defined as patients whose sputum smear or culture is positive at 5 months or later during treatment.

Time frame: two-month course intensive phase treatment, followed by a four-month consolidation phase treatment.Some TB patients with cavity should receive 9 total months (7 months of continuation therapy after the initial 2-month intensive phase).

Central Contacts

Naihui Chu, PhD

CONTACT

dongchu1994@sina.com

Data from ClinicalTrials.gov

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