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

NCT ID: NCT05395702

Last Updated: 2022-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-12
• Study Completion Date: 2019-05-30

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.

Conditions

Community-acquired Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Drug: Interferon Gamma

Antibacterial therapy + IFN-G administered intramuscularly 100,000 IU once a day daily for 5 days

Group Type: EXPERIMENTAL

Interferon-Gamma

Intervention Type: DRUG

received by microbiological synthesis; specific antiviral activity on cells is 2x10\*7 Units per mg of protein

Control: No intervention

Only antibacterial therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Interferon-Gamma

received by microbiological synthesis; specific antiviral activity on cells is 2x10\*7 Units per mg of protein

Intervention Type: DRUG

Other Intervention Names

Ingaron; Interferon gamma human recombinant

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SPP Pharmaclon Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anatoly I Saulin, Master

Role: STUDY_DIRECTOR

SPP Pharmaclon Ltd.

Locations

City Clinical Hospital named after M.E. Zhadkevich Moscow City Health Department

Moscow, , Russia

Countries

Russia

References

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.

Reference Type: RESULT

Other Identifiers

IN/100000-317

Identifier Type: -

Identifier Source: org_study_id