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Community-acquired PneumoniaNCT05395702

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

A study testing Interferon-Gamma in people with Community-acquired Pneumonia, run by SPP Pharmaclon Ltd. at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Community-acquired Pneumonia
What is being tested?
Interferon-Gamma
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
1 siteRussia
Study dates
12 May 2017to 30 May 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Russia1 site

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

    Moscow, 121374

Other trials in Russia

About this study

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

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.

Read the 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.

Being tested
Interferon-Gamma
Keywords
interferon gamma, IFN-g, antibiotic resistance, Community-acquired Pneumonia
Medical subject headings
Community-Acquired Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interferon-GammaDrug

    Also called Ingaron, Interferon gamma human recombinant

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

Study groups in NCT05395702
Study groupRoleWhat they receive
Drug: Interferon GammaExperimentalAntibacterial therapy + IFN-G administered intramuscularly 100,000 IU once a day daily for 5 days
Receives: Drug: Interferon-Gamma
Control: No interventionNo interventionOnly antibacterial therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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%

    Measured: Day 33

Secondary outcomes (16)

  1. 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

    Measured: Day 10

  2. 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

    Measured: Day 10

  3. Change in blood oxygen saturation

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

    Measured: Day 3

  4. Change in blood oxygen saturation

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

    Measured: Day 6

  5. Change in blood oxygen saturation

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

    Measured: Day 10

  6. 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

    Measured: Day 10

  7. 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

    Measured: Day 31

  8. 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

    Measured: Day 10

  9. 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

    Measured: Day 3

  10. 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

    Measured: Day 6

  11. 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

    Measured: Day 10

  12. 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

    Measured: Day 3

  13. 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

    Measured: Day 10

  14. ESR change

    ESR change at visit 4 relative to visit 0

    Measured: Day 10

  15. Change in bacterial count in sputum culture

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

    Measured: Day 10

  16. 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

    Measured: Day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2022
  2. Study start12 May 2017
  3. Primary completion27 Jul 2018
  4. Study completion30 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05395702
Sponsor's protocol ID
IN/100000-317
Status last verified
May 2022
First submitted
19 May 2022
Last updated
27 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Interferon-Gamma in people with Community-acquired Pneumonia, run by SPP Pharmaclon Ltd. at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to clinical stabilization of the patient's condition (time frame: Day 33). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05395702, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.

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