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Completed

NCT Number: NCT05395702

Study of Ingaron's Effect on Efficacy and Resistance to Antibiotics in 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.

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Key information

Conditions

Community-Acquired Pneumonia Community-Acquired Infections Infections Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Moscow, 121374, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

interferon-gamma

Drug

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

Other names: Ingaron, Interferon gamma human recombinant

Primary outcomes

  1. Time to clinical stabilization of the patient's condition

    Time frame: Day 33

    Assessed by the following parameters: HR < 100 bpm, RR < 24 resp./min, systolic blood pressure ≥90 mmHg, blood saturation level ≥ 90%

Secondary outcomes

  1. Change in the level of procalcitonin in the blood

    Time frame: Day 10

    Change in the level of procalcitonin in the blood at visit 4 relative to visit 0

  2. Change in the level of C-reactive protein in the blood

    Time frame: Day 10

    Change in the level of C-reactive protein in the blood at visit 4 relative to visit 0

  3. Change in blood oxygen saturation

    Time frame: Day 3

    Change in blood oxygen saturation at visit 2 relative to visit 0

  4. Change in blood oxygen saturation

    Time frame: Day 6

    Change in blood oxygen saturation at visit 3 relative to visit 0

  5. Change in blood oxygen saturation

    Time frame: Day 10

    Change in blood oxygen saturation at visit 4 relative to visit 0

  6. Borg Scale changes

    Time frame: 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

  7. Borg Scale changes

    Time frame: 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

  8. Change in the volume of infiltrates in the lungs according to X-ray data

    Time frame: Day 10

    Change in the volume of infiltrates in the lungs according to X-ray data at visit 4 relative to visit 0

  9. Difference between body temperature values

    Time frame: 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

  10. Difference between body temperature values

    Time frame: Day 6

    Difference between body temperature values (in case of symptom presence according to screening data) at visit 3 relative to visit 0

  11. Difference between body temperature values

    Time frame: Day 10

    Difference between body temperature values (in case of symptom presence according to screening data) at visit 4 relative to visit 0

  12. Change in the level of leukocytes in the blood

    Time frame: Day 3

    Change in the level of leukocytes in the blood at visit 2 relative to visit 0

  13. Change in the level of leukocytes in the blood

    Time frame: Day 10

    Change in the level of leukocytes in the blood at visit 4 relative to visit 0

  14. ESR change

    Time frame: Day 10

    ESR change at visit 4 relative to visit 0

  15. Change in bacterial count in sputum culture

    Time frame: Day 10

    Change in bacterial count in sputum culture at visit 4 relative to visit 0

  16. Proportion of patients with antibiotic therapy failure

    Time frame: 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

Sponsors and collaborators

Lead sponsor

SPP Pharmaclon Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
May 27, 2022
Registry last updated
May 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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