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

Sponsor

SPP Pharmaclon Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT05395702

Collaborator

(none)

114

Enrollment

Location

Arms

24.6

Actual Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Community-acquired Pneumonia	Drug: Interferon-Gamma	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

114 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 12, 2017

Actual Primary Completion Date :

Jul 27, 2018

Actual Study Completion Date :

May 30, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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 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
Change in blood oxygen saturation [Day 3]
Change in blood oxygen saturation at visit 2 relative to visit 0
Change in blood oxygen saturation [Day 6]
Change in blood oxygen saturation at visit 3 relative to visit 0
Change in blood oxygen saturation [Day 10]
Change in blood oxygen saturation at visit 4 relative to visit 0
Borg Scale changes [Day 10]
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
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
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
Difference between body temperature values [Day 3]
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
Difference between body temperature values [Day 6]
Difference between body temperature values (in case of symptom presence according to screening data) at visit 3 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 leukocytes in the blood [Day 3]
Change in the level of leukocytes in the blood at visit 2 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
ESR change [Day 10]
ESR change 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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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.