Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug: Interferon Gamma | Experimental | Antibacterial therapy + IFN-G administered intramuscularly 100,000 IU once a day daily for 5 days |
|
| Control: No intervention | No Intervention | Only antibacterial therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon-Gamma | Drug | received by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to clinical stabilization of the patient's condition | Assessed by the following parameters: HR < 100 bpm, RR < 24 resp./min, systolic blood pressure ≥90 mmHg, blood saturation level ≥ 90% | Day 33 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the level of procalcitonin in the blood | Change in the level of procalcitonin in the blood at visit 4 relative to visit 0 | Day 10 |
| Change in the level of C-reactive protein in the blood |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anatoly I Saulin, Master | SPP Pharmaclon Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City Clinical Hospital named after M.E. Zhadkevich Moscow City Health Department | Moscow | 121374 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Belevsky AS, Berns SA, Lartseva OA, Myasnikov AL, Nadaraya VM, Talyzin PA. Efficacy and safety of interferon gamma in the treatment of community-acquired pneumonia: results of an open-label randomized trial IN/100000-317. Meditsina. 2019; 4: 110-25. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D007371 | Interferon-gamma |
| ID | Term |
|---|---|
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Change in the level of C-reactive protein in the blood at visit 4 relative to visit 0
| Day 10 |
| Change in blood oxygen saturation | Change in blood oxygen saturation at visit 2 relative to visit 0 | Day 3 |
| Change in blood oxygen saturation | Change in blood oxygen saturation at visit 3 relative to visit 0 | Day 6 |
| Change in blood oxygen saturation | Change in blood oxygen saturation at visit 4 relative to visit 0 | Day 10 |
| Borg Scale changes | 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 | Day 10 |
| Borg Scale changes | Changes on the Borg Scale during a phone call relative to visit 0, where the minimum score is 0 - shortness of breath does not bother, the maximum score is 10 - shortness of breath is very pronounced | Day 31 |
| Change in the volume of infiltrates in the lungs according to X-ray data | Change in the volume of infiltrates in the lungs according to X-ray data at visit 4 relative to visit 0 | Day 10 |
| Difference between body temperature values | 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 | Day 3 |
| Difference between body temperature values | Difference between body temperature values (in case of symptom presence according to screening data) at visit 3 relative to visit 0 | Day 6 |
| Difference between body temperature values | Difference between body temperature values (in case of symptom presence according to screening data) at visit 4 relative to visit 0 | Day 10 |
| Change in the level of leukocytes in the blood | Change in the level of leukocytes in the blood at visit 2 relative to visit 0 | Day 3 |
| Change in the level of leukocytes in the blood | Change in the level of leukocytes in the blood at visit 4 relative to visit 0 | Day 10 |
| ESR change | ESR change at visit 4 relative to visit 0 | Day 10 |
| Change in bacterial count in sputum culture | Change in bacterial count in sputum culture at visit 4 relative to visit 0 | Day 10 |
| Proportion of patients with antibiotic therapy failure | 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 | Day 3 |
| D012140 |
| Respiratory Tract Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D016215 | Macrophage-Activating Factors |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |