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Pharmacogenomic Biomarker Study for Recombinant Human Activated Protein C Treatment in Severe Sepsis

NCT01486524 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2011-12-06

No results posted yet for this study

Summary

The overall purpose of the study is to determine whether either of the Improved Response Polymorphisms (IRPs) individually predicts a differential DrotAA treatment effect in patients with severe sepsis and high risk of death. This will be an international, multicenter, "prospective-retrospective", nonrandomized, controlled, outcome-blinded, genotype-blinded, matched-patients study. No prospective enrollment or treatment of patients will occur under this protocol. Retrospectively collected clinical data and DNA samples will be analyzed for existing cohorts of patients with severe sepsis who were previously treated with DrotAA (treatment group) or not (control group) as part of their standard care in an ICU.

Conditions

  • Severe Sepsis
  • Septic Shock

Sponsors & Collaborators

  • Sirius Genomics Inc.

    lead INDUSTRY

Principal Investigators

  • Djillali Annane, MD, PhD · University of Versailles

  • Alexandra DJ Mancini, MSc · Sirius Genomics Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United States
  • Canada
  • France
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01486524 on ClinicalTrials.gov