Preclinical Detection of Sepsis Early in Hospitalized Patients Following Surgery, Injury or Severe Illness

NCT04189549 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2019-12-06

No results posted yet for this study

Summary

This clinical study is to evaluate a novel biomarker - CNA Rapid Sepsis Dx - to predict the development of sepsis in patients admitted to the hospital with non-sepsis conditions. Using circulating cell-free DNA (cfDNA) in the blood stream, it has been demonstrated to detect infection response days before clinical evidence of sepsis manifests. The hypothesis is that blood biomarkers drawn daily in the hospital will identify patients who develop sepsis within seven days of hospital presentation.

Conditions

Interventions

DIAGNOSTIC_TEST

CNA Rapid Sepsis Dx

Novel biomarker based on circulating cell-free DNA (cfDNA) in the human blood stream

Sponsors & Collaborators

  • Robert Ehrman

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-09
Primary Completion
2020-11-01
Completion
2021-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT04189549 on ClinicalTrials.gov