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

Status unconfirmed

Conditions studied: Sepsis

In brief

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.

Key facts

Study ID

NCT04189549

Run by

Robert Ehrman

People needed

2000

Starts

2019-12-09

Expected to finish

2021-04-30

Last updated by the study team

2019-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient 18 years of age or older at the time of enrollment
• Presence of any of the following high-risk features:
• Victims of trauma with either an Injury Severity Score of ≥ 15 or a Glasgow Coma Score of ≤ 8[2] OR
• Any patient undergoing high-risk surgical procedures including any emergency surgery and high risk elective surgery procedures involving the thorax, esophagus, stomach, small bowel, large bowel [3, 4] OR
• Any patient being admitted to any ICU setting for any reason with no current evidence or suspicion of active infection (by primary team).[5, 6]
• Able to collect sample within 24 hours of presentation to the hospital.

You may not qualify if…

• Prisoners or in police custody
• Pregnancy
• Pre-existing infection for which patient is being treated with antibiotics as an outpatient.
• Plan for ongoing antibiotic therapy by treating team (up to three doses antibiotics for peri-procedure prophylaxis is allowable).
• Moribund, unlikely to survive the duration of active enrollment
• Comfort care measures in place or ordered at time of screening OR indication from treating team that active medical care will not be pursued due to patient's condition or patient's/family's wishes.
• Palliative care or hospice consult at time of screening.

Where it is running

• University of Alabama Birmingham — Birmingham, Alabama, United States
• Detroit Receiving Hospital — Detroit, Michigan, United States
• Harper University Hospital — Detroit, Michigan, United States
• Sinai-Grace Hospital — Detroit, Michigan, United States
• Northwell Health — New York, New York, United States

Full record on ClinicalTrials.gov

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