NCT05395702

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: SPP Pharmaclon Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Community-acquired Pneumonia

Interventions

Type	Name	Description
DRUG	Interferon-Gamma	received by microbiological synthesis; specific antiviral activity on cells is 2x10\*7 Units per mg of protein

Timeline

• Start date: 2017-05-12
• Primary completion: 2018-07-27
• Completion: 2019-05-30
• First posted: 2022-05-27
• Last updated: 2022-05-27

Locations

1 site across 1 country: Russia