Change in company strategy

The purpose of the study is to procure blood samples from patients ≥18 years of age who present to the Emergency Department (ED) with at least two of the diagnostic criteria for sepsis. Samples obtained upon enrollment will be used for future testing of the Triage Sepsis Panel and other biomarkers.

This is a multi-center, prospective specimen procurement study. The samples will be used for future testing of the Triage Sepsis Panel in conjunction with other laboratory tests and clinical assessments as an aid in the assessment for risk of sepsis progression within 72 hours of patients presenting in the Emergency Department and meeting the diagnostic criteria for sepsis who might be considered for hospital admission, including to the ICU. Approximately 700 patients presenting to the Emergency Department (ED) with at least two of the symptoms or signs of sepsis will be enrolled in this study.

The day of enrollment is defined as Study Day 0. Enrolled patients who are discharged to home will be contacted by telephone on Study Days 3, 14 and 28 to assess their clinical status.

Patients who are admitted to the hospital following initial enrollment will undergo the following assessments at 24, 48 and 72 hours after enrollment and at discharge (if in the hospital and alive at these time points).

Each patient will also be contacted on Study Day 14 and on or after Study Day 28 to assess the duration of hospital stay and mortality through Days 14 and 28.

Inclusion Criteria:

• Male or female 18 years of age or older
• Presenting to the emergency department (ED) for evaluation and who can be enrolled within 6 hours of initial ED evaluation
• Exhibiting two or more of any diagnostic criteria for sepsis
• Willing and able to comply with study procedures, including follow-up telephone contact (or in-house assessment) on Study Days 3, 14, and 28

Exclusion Criteria:

• Age < 18 years
• Participation in any interventional clinical study within the previous 30 days
• Status-post cardiac arrest (within the past month)
• Moribund or with active "Do Not Resuscitate" or "Comfort Care Only" status
• Prisoners or other institutionalized or vulnerable individuals
• Already a hospital in-patient
• Unwilling or unlikely to comply with study procedures or to be reachable by telephone (or in person) for Day 3, 14, and 28 status assessments if discharged