Pilot Single-center Open Study of the Effect of Ingaron on the Efficacy and Resistance to Antibiotics in Antibacterial Therapy in Patients With Community-acquired Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Time to clinical stabilization of the patient's condition
研究概览
简要总结
The primary purpose of this study is to effect of Ingaron®, a lyophilisate for the preparation of a solution for intramuscular and subcutaneous administration of 100,000 IU (LLC NPP Farmaklon, Russia) on the effectiveness of antibiotic therapy in patients with community-acquired pneumonia who fell ill during the epidemiological rise of ARVI.
详细描述
Pilot, open, single-centre, randomized controlled trial. Patients will be prescribed basic combination antibiotic therapy. In addition to antibiotic therapy, half of the patients will receive Ingaron®, a lyophilisate for the preparation of a solution for intramuscular and subcutaneous administration of 100,000 IU (LLC NPP Farmaklon, Russia). The study drug solution Ingaron® will be administered intramuscularly at 100,000 IU once daily for 5 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of the inpatient department of both sexes aged 18 to 60 years.
- •Confirmed diagnosis - community-acquired pneumonia (causative agent not specified) of an uncomplicated typical course without respiratory failure and the duration of symptoms is not more than 14 days.
- •Risk class of lethal outcome I-II according to the Fine scale.
- •Availability of an Informed Consent voluntarily signed by the patient.
排除标准
- •Increased individual sensitivity to gamma interferon, Ingaron® and / or excipients that are part of Ingaron® or drugs used in antibacterial therapy.
- •The use of immunomodulating, immunostimulating or immunosuppressive therapy later than 1 month before enrollment in the study.
- •Bronchial asthma and/or COPD.
- •Congestive heart failure.
- •Acute diseases of the gastrointestinal tract or other pathologies that may affect the absorption, distribution, metabolism or excretion of drugs.
- •Chronic liver and / or kidney disease or other pathologies that may affect the absorption, distribution, metabolism or excretion of drugs.
- •Oncological diseases, autoimmune, immunosuppressive conditions at present or according to history.
- •Cerebrovascular pathologies.
- •Pregnancy or lactation.
- •Smoking index over 10 pack/years.
- •Data on severe nervous or mental diseases, including history.
- •Violation of consciousness.
- •Participation of the patient in other studies with the use of drugs or other methods of therapy, including clinical, currently or later than 1 month before inclusion in the study.
研究组 & 干预措施
Drug: Interferon Gamma
Antibacterial therapy + IFN-G administered intramuscularly 100,000 IU once a day daily for 5 days
干预措施: Interferon-Gamma (Drug)
结局指标
主要结局
Time to clinical stabilization of the patient's condition
时间窗: Day 33
Assessed by the following parameters: HR \< 100 bpm, RR \< 24 resp./min, systolic blood pressure ≥90 mmHg, blood saturation level ≥ 90%
次要结局
- Borg Scale changes(Day 31)
- ESR change(Day 10)
- Change in blood oxygen saturation(Day 10)
- Change in the level of C-reactive protein in the blood(Day 10)
- Difference between body temperature values(Day 10)
- Change in the level of procalcitonin in the blood(Day 10)
- Change in the level of leukocytes in the blood(Day 10)
- Change in bacterial count in sputum culture(Day 10)
- Change in the volume of infiltrates in the lungs according to X-ray data(Day 10)
- Proportion of patients with antibiotic therapy failure(Day 3)