TriVerity In The Diagnosis And Prognosis Of Emergency Department Patients With Suspected Infections And Suspected Sepsis (“SEPSIS-SHIELD”)

Overview

About this study

The purpose of this study is to analyze biological samples collected from participants with suspected infections to test the efficacy of the InSep test in development.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age >18 year.
  • Suspected Suspected acute infection (respiratory, urinary, abdominal, skin & soft-tissue), and at least one of the symptoms; OR
  • Suspected sepsis of any cause as defined by a blood culture order by the treating physician, and at least two of the symptoms:
    • Heart rate: > 90 beats/ minute;
    • Temperature: > 38C or < 36C;
    • Respiratory Rate: > 20 breaths / minutes or PaO2 of < 60 mmHg or SpO2 < 90%;
    • Systolic blood pressure: < 100 mmHg;
    • Altered mental status: Per clinical exam.
  • Able to provide informed consent, or consent by legally authorized representative.

Exclusion Criteria:

  • Patient-reported treatment with systemic antibiotics, systemic antiviral agents, or systemic antifungal agents within the past 7 days prior to the emergency department study visit. Participants will not be excluded for the following:
    • Use of topical antibiotics, topical antiviral or topical antifungal agents;
    • Use of peri-operative (prophylactic) antibiotics;
    • Use of a single dose of antibiotics during the present ED visit (< 6h before blood draw).
  • Prisoners, mentally disabled, or unable to give consent. Should the patient not be able to provide informed consent the legally authorized representative can provide the consent on behalf of the patient..
  • Previously enrolled in the present clinical trial.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Casey Clements, M.D., Ph.D.

Closed for enrollment

More information

Publications

Publications are currently not available
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CLS-20486931

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