Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT03824457
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03824457
Study Brief:
Protocol Section:
NCT03824457