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

SPP Pharmaclon

Status

Completed

Conditions

Community-acquired Pneumonia

Treatments

Drug: Interferon-Gamma

Study type

Interventional

Funder types

Industry

Identifiers

NCT05395702

IN/100000-317

Details and patient eligibility

About

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.

Full 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.

Enrollment

114 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.
Diabetes.
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.