An Open Prospective Observational Study Evaluating the Efficacy and Tolerability of Interferon Gamma (Ingaron) Injections in Patients With Drug-resistant Pulmonary Tuberculosis
试验速览
- 阶段
- 不适用
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Sputum smear conversion according to microscopy.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and tolerability of the complex therapy of drug-resistant respiratory tuberculosis using the drug Ingaron, a lyophilisate for the preparation of a solution for injection for intramuscular or subcutaneous administration of 500,000 IU.
详细描述
Open prospective observational cohort study. During the recruitment phase, a preliminary assessment of eligibility and non-inclusion criteria will be carried out.
Subject to prior compliance with all inclusion criteria and none of the exclusion criteria, after signing a voluntary informed consent, the patient will be included in the study.
Patients will be divided into groups, depending on the therapy prescribed to them as part of routine clinical practice (according to clinical guidelines):
Group 1:
Pathogenetic therapy with the use of the drug Ingaron + basic anti-tuberculosis therapy in accordance with approved clinical guidelines.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or non-pregnant women 18-75 years of age.
- •For women of childbearing age who are fertile: Agree to completely abstain from sexual intercourse or use dual methods of contraception to prevent pregnancy while participating in the study.
- •Verified diagnosis of pulmonary tuberculosis (infiltrative tuberculosis, fibrous-cavernous tuberculosis in the infiltration phase).
- •A positive sputum smear microscopy test result for acid-fast bacterium, assessed as moderate (++) or massive bacterial excretion (+++) no earlier than 30 days prior to enrollment in the study.
- •Established resistance of the isolated pathogen to at least rifampicin, determined by molecular genetic or cultural methods for determining drug susceptibility.
- •Prescribing the current baseline chemotherapy regimen according to clinical guidelines no earlier than 14 days prior to enrollment in the study.
- •Compliance with prescribed therapy.
- •No concomitant immunotherapy, or 6 months from the last dose of an immunomodulatory drug to the start of therapy.
- •Absence of comorbidities and therapy that may affect the interpretation of study results, in the opinion of the investigator.
- •Signed written informed consent to participate in the study.
- •Willingness and ability to follow protocol requirements throughout the study.
排除标准
- •For women: pregnant, breastfeeding or planning a pregnancy during the study period.
- •Caseous pneumonia.
- •Asthma, with the exception of mild intermittent asthma.
- •Systemic fungal infections.
- •Use of any investigational drug within 30 days prior to screening.
- •Oncological diseases (cytotoxic chemotherapy, current or received within the last 3 months before the start of treatment).
- •Chronic diseases of the liver or kidneys (an increase in liver transaminases more than 5 times the upper limit of laboratory norms for these indicators; an increase in creatinine above 2 mg / 100 ml (or μmol / l)).
- •Diabetes.
- •HIV infection or other immunodeficiency conditions.
- •Inability, in the opinion of the investigator, to comply with the treatment regimen and the requirements of the study protocol.
研究组 & 干预措施
Experimental
Ingaron + basic TB therapy 500,000 IU once daily for 3 months followed by 3 months follow-up
干预措施: Interferon-Gamma (Drug)
结局指标
主要结局
Sputum smear conversion according to microscopy.
时间窗: 6 months
Sputum smear conversion according to microscopy. Mean time to clinical response.
Sputum smear conversion by culture.
时间窗: 6 months
Sputum smear conversion by culture. Mean time to clinical response.
次要结局
- The effectiveness of therapy according to X-ray examination of the chest.(6 months)
- The effectiveness of therapy according to computed tomography of the chest.(6 months)
- The effectiveness of therapy according to clinical examination.(6 months)
- Change in immunological status (CD4 and CD8 lymphocyte populations) compared with baseline values (before therapy).(6 months)
- Mortality rate.(6 months)