Study of Ingaron's Effect on Efficacy and Resistance to Antibiotics in Community-acquired Pneumonia

SPP Pharmaclon Ltd.114 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

114

Conditions

Community-acquired Pneumonia

Interventions

Interferon-GammaDRUG

received by microbiological synthesis; specific antiviral activity on cells is 2x10\*7 Units per mg of protein

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

City Clinical Hospital named after M.E. Zhadkevich Moscow City Health Department

Moscow, Russia

Outcomes

Primary Outcomes

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%

Time frame: Day 33

Secondary Outcomes

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

Time frame: Day 10

Change in the level of C-reactive protein in the blood

Change in the level of C-reactive protein in the blood at visit 4 relative to visit 0

Time frame: Day 10

Change in blood oxygen saturation

Change in blood oxygen saturation at visit 2 relative to visit 0

Time frame: Day 3

Change in blood oxygen saturation

Change in blood oxygen saturation at visit 3 relative to visit 0

Time frame: Day 6

Change in blood oxygen saturation

Change in blood oxygen saturation at visit 4 relative to visit 0

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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