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

• Conditions: Sepsis

• Registration Number: NCT04189549
• Lead Sponsor: Robert Ehrman

Brief 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.

Detailed Description

This is a prospective observational trial evaluating CNA Rapid Sepsis Dx -novel biomarkers (CNA Diagnostics Inc.; Calgary, Canada) based on circulating cell-free DNA (cfDNA) in the blood stream to identify patients originally admitted with non-sepsis conditions who ultimately develop sepsis according to Sepsis-3 criteria within seven days of hospital presentation. This novel technology has been demonstrated to detect host-related response to infection days before clinical evidence of sepsis manifests.

The primary objective of this study is to assess the performance of the novel diagnostic assay, CNA Rapid Sepsis Dx, based on the biomarkers, drawn daily from the day of hospital presentation, to identify patients who ultimately develop sepsis according to Sepsis-3-definition within seven days of hospital presentation.

The secondary objective is to correlate the CNA Rapid Sepsis Dx with clinically relevant outcomes such as infections that otherwise do not meet Sepsis-3 criteria, intensive care unit (ICU) length of stay, hospital length of stay, fluid culture results, and hospital mortality.

Study Timeline

• Status Verified: 2019-12
• Study First Submitted: 2019-12-02
• Study First Submitted QC: 2019-12-04
• Last Update Submitted: 2019-12-04
• Study First Posted: 2019-12-06
• Last Update Posted: 2019-12-06
• Study Start: 2019-12-09
• Primary Completion: 2020-11-01
• Study Completion: 2021-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

1. Patient 18 years of age or older at the time of enrollment

2. 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]

3. Able to collect sample within 24 hours of presentation to the hospital.

Exclusion Criteria

1. Prisoners or in police custody
2. Pregnancy
3. Pre-existing infection for which patient is being treated with antibiotics as an outpatient.
4. Plan for ongoing antibiotic therapy by treating team (up to three doses antibiotics for peri-procedure prophylaxis is allowable).
5. Moribund, unlikely to survive the duration of active enrollment
6. 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.
7. Palliative care or hospice consult at time of screening.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical development of sepsis	Seven Days from hospital presentation	Sepsis determined according to Sepsis-3 definition

Secondary Outcome Measures

Name	Time	Method
SIRS sepsis	Seven Days from hospital presentation	Infection with systemic inflammatory response syndrome (SIRS) criteria
Development of non-Sepsis 3 Infections	Seven Days from hospital presentation	An infection is suspected (by any degree of confidence) but the subject does not meet criteria for either Sepsis-3 or SIRS sepsis.
Hospital Length of Stay	Up to 12 months	Duration of hospital stay in survivors and non-survivors from date/time of hospital presentation to order for discharge.
Body Fluid Culture Results	Seven Days from hospital presentation	All fluid culture results (blood, CSF, urine, synovial, ascitic, abscess, etc) collected during the study period will be recorded
Intensive Care Unit Length of Stay	Up to 6 months	Duration of ICU stay in survivors and non-survivors from date/time of ICU admission to date/time order for transfer / discharge from ICU.

Trial Locations

Locations (5)

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