A Multicenter Clinical Trial of Recombinant Human Interferon Gamma (Ingaron) in Pulmonary Tuberculosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 13
- 主要终点
- Proportion of abacillated patients
研究概览
简要总结
The main purpose of testing: To confirm the effectiveness and safety of the drug Ingaron when used in patients hospitalized at the research center for various reasons.
详细描述
Monitoring of a patient in a hospital is carried out daily by the attending physician during the entire period of the patient's stay at the research center. When prescribing the drug Ingaron, the researcher must follow the instructions for use of the drug. As part of 4 control observations to assess effectiveness and safety:
- 1st on the 1st day of using the drug Ingaron and starting anti-tuberculosis therapy
- 2nd on the 30th - 31st day of therapy
- 3rd after 2 months of therapy
- 4th (final) after 3 months of follow-up After each of the 3 visits, the research doctor saves the data necessary for further evaluation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 78 years inclusive
- •Bacterioscopically and/or molecularly genetically verified diagnosis of tuberculosis
- •Stay in the intensive phase of treatment
- •Consent to inpatient anti-tuberculosis therapy until the end of participation in clinical observation
排除标准
- •Serious condition
- •Breastfeeding
- •Treatment with immunomodulatory drugs before inclusion in the observation program
- •Presence of medical history of an allergic reaction or individual intolerance to the drug Ingaron
- •Severe diseases of the liver, kidneys (creatinine more than 150 mmol/l)
- •Presence of contraindications to the administration of the drug Ingaron
- •Patients with HIV infection with a CD4 lymphocyte count less than 350 cells/ml
研究组 & 干预措施
Experimental
Ingaron 500,000 IU intramuscularly 1 time per day daily or every other day for 2 months (60 days) - a total of 30 or 60 injections + basic anti-tuberculosis therapy
干预措施: Interferon-Gamma (Drug)
结局指标
主要结局
Proportion of abacillated patients
时间窗: 2 month
Proportion of abacillated patients according to culture data
次要结局
- Proportion of patients who died(5 month)
- Changes in the level of CD4 lymphocytes and HIV viral load in the blood(5 month)
- Proportion of patients who required a change in therapy(5 month)
- Proportion of patients with adverse reactions(5 month)