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

Not Applicable

Completed

• Conditions: Community-acquired Pneumonia
• Interventions: Drug: Interferon-Gamma

• Registration Number: NCT05395702
• Lead Sponsor: SPP Pharmaclon Ltd.

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.

Study Timeline

• Study Start: 2017-05-12
• Primary Completion: 2018-07-27
• Study Completion: 2019-05-30
• Status Verified: 2022-05
• Study First Submitted: 2022-05-19
• Study First Submitted QC: 2022-05-24
• Last Update Submitted: 2022-05-24
• Study First Posted: 2022-05-27
• Last Update Posted: 2022-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug: Interferon Gamma	Interferon-Gamma	Antibacterial therapy + IFN-G administered intramuscularly 100,000 IU once a day daily for 5 days

Primary Outcome Measures

Name	Time	Method
Time to clinical stabilization of the patient's condition	Day 33	Assessed by the following parameters: HR \< 100 bpm, RR \< 24 resp./min, systolic blood pressure ≥90 mmHg, blood saturation level ≥ 90%

Secondary Outcome Measures

Name	Time	Method
Borg Scale changes	Day 31	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
ESR change	Day 10	ESR change at visit 4 relative to visit 0
Change in blood oxygen saturation	Day 10	Change in blood oxygen saturation at visit 4 relative to visit 0
Change in the level of C-reactive protein in the blood	Day 10	Change in the level of C-reactive protein in the blood at visit 4 relative to visit 0
Difference between body temperature values	Day 10	Difference between body temperature values (in case of symptom presence according to screening data) at visit 4 relative to visit 0
Change in the level of procalcitonin in the blood	Day 10	Change in the level of procalcitonin in the blood at visit 4 relative to visit 0
Change in the level of leukocytes in the blood	Day 10	Change in the level of leukocytes in the blood at visit 4 relative to visit 0
Change in bacterial count in sputum culture	Day 10	Change in bacterial count in sputum culture at visit 4 relative to visit 0
Change in the volume of infiltrates in the lungs according to X-ray data	Day 10	Change in the volume of infiltrates in the lungs according to X-ray data at visit 4 relative to visit 0
Proportion of patients with antibiotic therapy failure	Day 3	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

Trial Locations

Locations (1)

City Clinical Hospital named after M.E. Zhadkevich Moscow City Health Department; 🇷🇺 Moscow, Russian Federation