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NCT04189549: Pre-SEPSIS

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

Status unknown Last updated 6 December 2019
What this trial tests

trial testing CNA Rapid Sepsis Dx in Sepsis in 2,000 participants. Status unknown.

Timeline
9 December 2019
Primary endpoint
1 November 2020
30 April 2021

Quick facts

Lead sponsorRobert Ehrman
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment2,000
Start date9 December 2019
Primary completion1 November 2020
Estimated completion30 April 2021
Sites5 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Robert Ehrman

Who can join

18 and older, any sex, with Sepsis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Current Trends in Cell-Free DNA Applications. Scoping Review of Clinical Trials.
    Stawski R, Stec-Martyna E, Chmielecki A, Nowak D, et al · · 2021 · cited 20× · PMID 34571783 · DOI 10.3390/biology10090906

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