Clinical trial NCT05395702: Study of Ingaron's Effect on Efficacy and Resistance to Antibiotics in Community-acquired Pneumonia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Community-acquired Pneumonia
Keywords: interferon gamma
IFN-g
antibiotic resistance
Community-acquired Pneumonia
Lead sponsor: SPP Pharmaclon Ltd.
Sponsor class: INDUSTRY
First posted: 2022-05-27
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to clinical stabilization of the patient's condition
timeFrame: Day 33
Secondary outcomes:
measure: Change in the level of procalcitonin in the blood
timeFrame: Day 10
measure: Change in the level of C-reactive protein in the blood
timeFrame: Day 10
measure: Change in blood oxygen saturation
timeFrame: Day 3
measure: Change in blood oxygen saturation
timeFrame: Day 6
measure: Change in blood oxygen saturation
timeFrame: Day 10
measure: Borg Scale changes
timeFrame: Day 10
measure: Borg Scale changes
timeFrame: Day 31
measure: Change in the volume of infiltrates in the lungs according to X-ray data
timeFrame: Day 10
measure: Difference between body temperature values
timeFrame: Day 3
measure: Difference between body temperature values
timeFrame: Day 6
measure: Difference between body temperature values
timeFrame: Day 10
measure: Change in the level of leukocytes in the blood
timeFrame: Day 3
measure: Change in the level of leukocytes in the blood
timeFrame: Day 10
measure: ESR change
timeFrame: Day 10
measure: Change in bacterial count in sputum culture
timeFrame: Day 10
measure: Proportion of patients with antibiotic therapy failure
timeFrame: Day 3
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: City Clinical Hospital named after M.E. Zhadkevich Moscow City Health Department
Study officials:
affiliation: SPP Pharmaclon Ltd.
name: Anatoly I Saulin, Master
role: STUDY_DIRECTOR
References:
citation: 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.