Community-acquired Pneumonia
Conditions
Keywords
interferon gamma, IFN-g, antibiotic resistance, Community-acquired Pneumonia
Brief summary
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.
Detailed description
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.
Interventions
DRUGInterferon-Gamma
received by microbiological synthesis; specific antiviral activity on cells is 2x10\*7 Units per mg of protein
Sponsors
SPP Pharmaclon Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Patients of the inpatient department of both sexes aged 18 to 60 years. 2. 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. 3. Risk class of lethal outcome I-II according to the Fine scale. 4. Availability of an Informed Consent voluntarily signed by the patient.
Exclusion criteria
1. Increased individual sensitivity to gamma interferon, Ingaron® and / or excipients that are part of Ingaron® or drugs used in antibacterial therapy. 2. The use of immunomodulating, immunostimulating or immunosuppressive therapy later than 1 month before enrollment in the study. 3. Bronchial asthma and/or COPD. 4. Congestive heart failure. 5. Acute diseases of the gastrointestinal tract or other pathologies that may affect the absorption, distribution, metabolism or excretion of drugs. 6. Chronic liver and / or kidney disease or other pathologies that may affect the absorption, distribution, metabolism or excretion of drugs. 7. Oncological diseases, autoimmune, immunosuppressive conditions at present or according to history. 8. Cerebrovascular pathologies. 9. Diabetes. 10. Pregnancy or lactation. 11. Smoking index over 10 pack/years. 12. Data on severe nervous or mental diseases, including history. 13. Violation of consciousness. 14. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to clinical stabilization of the patient's condition | Day 33 | Assessed by the following parameters: HR \< 100 bpm, RR \< 24 resp./min, systolic blood pressure ≥90 mmHg, blood saturation level ≥ 90% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the level of C-reactive protein in the blood | Day 10 | Change in the level of C-reactive protein in the blood at visit 4 relative to visit 0 |
| Change in blood oxygen saturation | Day 3 | Change in blood oxygen saturation at visit 2 relative to visit 0 |
| Borg Scale changes | Day 10 | Changes on the Borg Scale at visit 4 relative to visit 0, where the minimum score is 0 - dyspnea does not bother, the maximum score is 10 - dyspnea is very pronounced |
| Change in the volume of infiltrates in the lungs according to X-ray data | Day 10 | Change in the volume of infiltrates in the lungs according to X-ray data at visit 4 relative to visit 0 |
| Change in the level of procalcitonin in the blood | Day 10 | Change in the level of procalcitonin in the blood at visit 4 relative to visit 0 |
| Change in the level of leukocytes in the blood | Day 3 | Change in the level of leukocytes in the blood at visit 2 relative to visit 0 |
| ESR change | Day 10 | ESR change at visit 4 relative to visit 0 |
| Change in bacterial count in sputum culture | Day 10 | Change in bacterial count in sputum culture at visit 4 relative to visit 0 |
| Proportion of patients with antibiotic therapy failure | Day 3 | Proportion of patients with antibiotic therapy failure, assessed by the need to change the therapy regimen (add drugs, replace them, or switch to a different dosing regimen or route of administration), lack of signs of clinical stabilization of the condition, or worsening of the course of pneumonia |
| Difference between body temperature values | Day 3 | Difference between body temperature values Difference between body temperature values (in case of symptom presence according to screening data) at visit 2 relative to visit 0 |
Countries
Russia
Outcome results
None listed