NL-OMON23213
Recruiting
Not Applicable
A phase I trial evaluating the safety, tolerability and pharmacokinetics of intravenously administered M6229 in critically ill sepsis patients – HistoSeps”
Amsterdam UMC, location AMC0 sites16 target enrollmentStarted: TBDLast updated:
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Amsterdam UMC, location AMC
- Enrollment
- 16
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female patients aged \= 18 years old.
- •2\. Signed informed consent by patient or legal representative.
- •3\. ICU admittance for sepsis defined by the Sepsis\-3 criteria as a life\-threatening organ dysfunction caused by a dysregulated host response to an infection.
- •Organ dysfunction is defined by 1 of the following:
- •a. Increase in SOFA score of \=2\.
- •i. The baseline SOFA score can be assumed to be zero in patients not known to have pre\-existing organ dysfunction.
- •b. Acute kidney injury
- •i. Defined as eGFR \< 15 mL/min.
- •c. Acute respiratory distress syndrome
- •i. Defined by the Berlin criteria.
Exclusion Criteria
- •1\. Subject has an advance directive to withhold life\-sustaining treatments.
- •2\. Subject is breastfeeding or intents to get pregnant within 30 days of enrolling into the study.
- •3\. Subject is of childbearing potential and has a positive pregnancy test.
- •a. A woman is considered to be of childbearing potential under the age of 60 years, unless surgically sterile.
- •4\. Clinical suspicion or confirmation of a viral hemorrhagic shock syndrome including, but not limited to, dengue fever.
- •5\. Bleeding risk:
- •a. Clinical:
- •i. Active bleeding;
- •ii. Head trauma;
- •iii. Intracranial surgery or stroke in the past 3 months;
Investigators
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