Status:
COMPLETED
Study of Ingaron's Effect on Efficacy and Resistance to Antibiotics in Community-acquired Pneumonia
Lead Sponsor:
SPP Pharmaclon Ltd.
Conditions:
Community-acquired Pneumonia
Eligibility:
All Genders
18-60 years
Phase:
NA
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)...
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®...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2019
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT05395702
Start Date
May 12 2017
End Date
May 30 2019
Last Update
May 27 2022
Active Locations (1)
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1
City Clinical Hospital named after M.E. Zhadkevich Moscow City Health Department
Moscow, Russia, 121374