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Clinical Trials/NL-OMON51932
NL-OMON51932
Completed
Not Applicable

A phase I trial evaluating the safety, tolerability and pharmacokinetics of intravenously administered M6229 in critically ill sepsis patients - *HistoSeps* - HistoSeps

Academisch Medisch Centrum0 sites26 target enrollmentStarted: TBDLast updated:
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Overview

Phase
Not Applicable
Status
Completed
Enrollment
26
OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 99 (—)

Inclusion Criteria

  • •1\. Male or female patients aged \>\= 18 year.
  • •2\. Signed informed consent by patient or legal representative.
  • •3\. Diagnosed with sepsis, defined by the Sepsis\-3 criteria as a
  • •life\-threatening organ dysfunction caused by a dysregulated host response to an
  • •4\. The patients have to be included in the study within 72 hours of ICU
  • •admission due to sepsis or within 72 hours after sepsis diagnosis on the ICU.
  • •M6229 has to be administered within 84 hours after ICU admission due to sepsis
  • •or within 84 hours after sepsis diagnosis on the ICU

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:

Investigators

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