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

Sepsis Clinical Trial

— Pre-SEPSIS  

Official title:

Preclinical Detection of Sepsis Early in Hospitalized Patients Following Surgery, Injury or Severe Illness (Pre-SEPSIS Trial)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04189549
• Other study ID #: 2019R110
• Status: Not yet recruiting
• Start date: December 9, 2019
• Est. completion date: April 30, 2021

Study information

• Verified date: December 2019
• Source: Wayne State University
• Contact: Patrick Medado
• Phone: 3135777500
• Email: pmedado[@]wayne.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: April 30, 2021
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Diagnostic Test:
• CNA Rapid Sepsis Dx
Novel biomarker based on circulating cell-free DNA (cfDNA) in the human blood stream

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Robert Ehrman

Country where clinical trial is conducted

United States, 

Outcome

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