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

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.

Study Overview

• Status: Completed
• Conditions: Community-acquired Pneumonia
• Intervention / Treatment: Drug: Interferon-Gamma

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 Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 121374
    • City Clinical Hospital named after M.E. Zhadkevich Moscow City Health Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Drug: Interferon Gamma; Antibacterial therapy + IFN-G administered intramuscularly 100,000 IU once a day daily for 5 days	Drug: Interferon-Gamma; received by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein; Other Names: Ingaron; Interferon gamma human recombinant
NO_INTERVENTION: Control: No intervention; Only antibacterial therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%	Day 33

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Day 10
Change in blood oxygen saturation	Change in blood oxygen saturation at visit 2 relative to visit 0	Day 3
Change in blood oxygen saturation	Change in blood oxygen saturation at visit 3 relative to visit 0	Day 6
Change in blood oxygen saturation	Change in blood oxygen saturation at visit 4 relative to visit 0	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	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	Day 31
Change in the volume of infiltrates in the lungs according to X-ray data	Change in the volume of infiltrates in the lungs according to X-ray data at visit 4 relative to visit 0	Day 10
Difference between body temperature values	Difference between body temperature values Difference between body temperature values (in case of symptom presence according to screening data) at visit 2 relative to visit 0	Day 3
Difference between body temperature values	Difference between body temperature values (in case of symptom presence according to screening data) at visit 3 relative to visit 0	Day 6
Difference between body temperature values	Difference between body temperature values (in case of symptom presence according to screening data) at visit 4 relative to visit 0	Day 10
Change in the level of leukocytes in the blood	Change in the level of leukocytes in the blood at visit 2 relative to visit 0	Day 3
Change in the level of leukocytes in the blood	Change in the level of leukocytes in the blood at visit 4 relative to visit 0	Day 10
ESR change	ESR change at visit 4 relative to visit 0	Day 10
Change in bacterial count in sputum culture	Change in bacterial count in sputum culture at visit 4 relative to visit 0	Day 10
Proportion of patients with antibiotic therapy failure	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	Day 3

Collaborators and Investigators

• Sponsor: SPP Pharmaclon Ltd.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 12, 2017
• Primary Completion (ACTUAL): July 27, 2018
• Study Completion (ACTUAL): May 30, 2019

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: May 24, 2022
• First Posted (ACTUAL): May 27, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 27, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: antibiotic resistance; Community-acquired Pneumonia; interferon gamma; IFN-g
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Interferons; Interferon-gamma
• Other Study ID Numbers: IN/100000-317

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No