Back to resultsStudy of Ingaron's Effect on Efficacy and Resistance to Antibiotics in Community-acquired Pneumonia
Primary Purpose
Community-acquired Pneumonia
Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Interferon-Gamma
Sponsored by
About this trial
This is an interventional treatment trial for Community-acquired Pneumonia focused on measuring interferon gamma, IFN-g, antibiotic resistance, Community-acquired Pneumonia
Eligibility Criteria
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.
Sites / Locations
- City Clinical Hospital named after M.E. Zhadkevich Moscow City Health Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Drug: Interferon Gamma
Control: No intervention
Arm Description
Antibacterial therapy + IFN-G administered intramuscularly 100,000 IU once a day daily for 5 days
Only antibacterial therapy
Outcomes
Primary Outcome Measures
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%
Secondary Outcome Measures
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
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
Change in blood oxygen saturation
Change in blood oxygen saturation at visit 2 relative to visit 0
Change in blood oxygen saturation
Change in blood oxygen saturation at visit 3 relative to visit 0
Change in blood oxygen saturation
Change in blood oxygen saturation at visit 4 relative to visit 0
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
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
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
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
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
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
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
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
ESR change
ESR change at visit 4 relative to visit 0
Change in bacterial count in sputum culture
Change in bacterial count in sputum culture at visit 4 relative to visit 0
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05395702
Brief Title
Study of Ingaron's Effect on Efficacy and Resistance to Antibiotics in Community-acquired Pneumonia
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 12, 2017 (Actual)
Primary Completion Date
July 27, 2018 (Actual)
Study Completion Date
May 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SPP Pharmaclon Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-acquired Pneumonia
Keywords
interferon gamma, IFN-g, antibiotic resistance, Community-acquired Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drug: Interferon Gamma
Arm Type
Experimental
Arm Description
Antibacterial therapy + IFN-G administered intramuscularly 100,000 IU once a day daily for 5 days
Arm Title
Control: No intervention
Arm Type
No Intervention
Arm Description
Only antibacterial therapy
Intervention Type
Drug
Intervention Name(s)
Interferon-Gamma
Other Intervention Name(s)
Ingaron, Interferon gamma human recombinant
Intervention Description
received by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein
Primary Outcome Measure Information:
Title
Time to clinical stabilization of the patient's condition
Description
Assessed by the following parameters: HR < 100 bpm, RR < 24 resp./min, systolic blood pressure ≥90 mmHg, blood saturation level ≥ 90%
Time Frame
Day 33
Secondary Outcome Measure Information:
Title
Change in the level of procalcitonin in the blood
Description
Change in the level of procalcitonin in the blood at visit 4 relative to visit 0
Time Frame
Day 10
Title
Change in the level of C-reactive protein in the blood
Description
Change in the level of C-reactive protein in the blood at visit 4 relative to visit 0
Time Frame
Day 10
Title
Change in blood oxygen saturation
Description
Change in blood oxygen saturation at visit 2 relative to visit 0
Time Frame
Day 3
Title
Change in blood oxygen saturation
Description
Change in blood oxygen saturation at visit 3 relative to visit 0
Time Frame
Day 6
Title
Change in blood oxygen saturation
Description
Change in blood oxygen saturation at visit 4 relative to visit 0
Time Frame
Day 10
Title
Borg Scale changes
Description
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
Time Frame
Day 10
Title
Borg Scale changes
Description
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
Time Frame
Day 31
Title
Change in the volume of infiltrates in the lungs according to X-ray data
Description
Change in the volume of infiltrates in the lungs according to X-ray data at visit 4 relative to visit 0
Time Frame
Day 10
Title
Difference between body temperature values
Description
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
Time Frame
Day 3
Title
Difference between body temperature values
Description
Difference between body temperature values (in case of symptom presence according to screening data) at visit 3 relative to visit 0
Time Frame
Day 6
Title
Difference between body temperature values
Description
Difference between body temperature values (in case of symptom presence according to screening data) at visit 4 relative to visit 0
Time Frame
Day 10
Title
Change in the level of leukocytes in the blood
Description
Change in the level of leukocytes in the blood at visit 2 relative to visit 0
Time Frame
Day 3
Title
Change in the level of leukocytes in the blood
Description
Change in the level of leukocytes in the blood at visit 4 relative to visit 0
Time Frame
Day 10
Title
ESR change
Description
ESR change at visit 4 relative to visit 0
Time Frame
Day 10
Title
Change in bacterial count in sputum culture
Description
Change in bacterial count in sputum culture at visit 4 relative to visit 0
Time Frame
Day 10
Title
Proportion of patients with antibiotic therapy failure
Description
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
Time Frame
Day 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anatoly I Saulin, Master
Organizational Affiliation
SPP Pharmaclon Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
City Clinical Hospital named after M.E. Zhadkevich Moscow City Health Department
City
Moscow
ZIP/Postal Code
121374
Country
Russian Federation
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
result
Learn more about this trial
Study of Ingaron's Effect on Efficacy and Resistance to Antibiotics in Community-acquired Pneumonia
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