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

Community-acquired Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05395702
• Other study ID #: IN/100000-317
• Status: Completed
• Phase: N/A
• Start date: May 12, 2017
• Est. completion date: May 30, 2019

Study information

• Verified date: May 2022
• Source: SPP Pharmaclon Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 epidemiological rise of ARVI.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: May 30, 2019
• Est. primary completion date: July 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumonia

Intervention

Drug:
• Interferon-Gamma
received by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein

Locations

Country	Name	City	State
Russian Federation	City Clinical Hospital named after M.E. Zhadkevich Moscow City Health Department	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
SPP Pharmaclon Ltd.

Country where clinical trial is conducted

Russian Federation, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%	Day 33
Secondary	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	Day 10
Secondary	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	Day 10
Secondary	Change in blood oxygen saturation	Change in blood oxygen saturation at visit 2 relative to visit 0	Day 3
Secondary	Change in blood oxygen saturation	Change in blood oxygen saturation at visit 3 relative to visit 0	Day 6
Secondary	Change in blood oxygen saturation	Change in blood oxygen saturation at visit 4 relative to visit 0	Day 10
Secondary	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	Day 10
Secondary	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	Day 31
Secondary	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	Day 10
Secondary	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	Day 3
Secondary	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	Day 6
Secondary	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	Day 10
Secondary	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	Day 3
Secondary	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	Day 10
Secondary	ESR change	ESR change at visit 4 relative to visit 0	Day 10
Secondary	Change in bacterial count in sputum culture	Change in bacterial count in sputum culture at visit 4 relative to visit 0	Day 10
Secondary	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	Day 3