Efficacy and Safety of Rheosorbilact® Solution for Infusion, in a Complex Therapy of Pneumonia

• Status: Completed
• Trial end date: 2020-02-17
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the efficacy and safety of Rheosorbilact®, solution for infusion ("Yuria-Pharm" LLC), in comparison with Ringer's Lactate, solution for infusion, in a complex therapy of pneumonia. Half of participants will receive Rheosorbilact® in complex therapy, while the other half will receive Ringer's Lactate in complex therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yuria-Pharm

Criteria

Inclusion Criteria:

1. Men and women aged 18 to 45 years inclusive;

2. Community-acquired pneumonia with a prescription from the beginning of antibacterial therapy no more than 48 hours;

3. The risk class of pneumonia in the PSI/PORT index score is at least IV;

4. Informed consent for participation in the study signed by subject's own hand.

5. The baseline value of the SOFA scale ≥ 2 points.

Non-inclusion criteria:

1. Individual intolerance of the components of the study drug and reference preparation;

2. Hypersensitivity to sodium lactate;

3. Intravenous infusions of lactate- or sorbitol-containing products within 24 hours before enrollment;

4. Severe renal dysfunction (creatinine is more than 300 μmol/l or estimated creatinine clearance is less than 30 ml/min);

5. Pregnancy or breast-feeding;

6. Metabolic alkalosis;

7. Severe metabolic acidosis;

8. Intracerebral hemorrhage;

9. Any thromboembolism;

10. Decompensated cardiovascular failure;

11. Arterial hypertension III st;

12. Conditions associated with immunodeficiency (the use of cytostatics or system steroids, AIDS, diabetes mellitus);

13. Extracellular hyperhydration or hypervolemia;

14. Severe renal insuffiency (with oliguria/anuria);

15. Hyperkalemia;

16. Hypercalcemia;

17. Ascites associated with cirrhosis;

18. Conditions associated with increased lactate levels (hyperlactatemia > 2 mmol / l), including lactic acidosis, or impaired lactate uptake (including due severe hepatic insufficiency);

19. Concomitant therapy with cardiac glycosides.

Exclusion Criteria:

1. Infusion of the study drug or the comparator is started more than 12 hours after randomization;

2. Lack of data for community-acquired pneumonia (diagnosis not confirmed);

3. Withdrawal of the informed consent by the subject;

4. Investigator considers that the infusion therapy with either study drug or comparator may not be continued for safety reasons;

5. Development of conditions that prevent further use of the study drug/comparator before efficacy evaluation visit (Visit 3);

6. Subject needs concomitant therapy prohibited in the study before efficacy evaluation visit (Visit 3);

7. Development of conditions (including serious adverse events) which make it impossible to evaluate the primary endpoint;

8. Confirmation of pregnancy at any time of the study.