TriVerity in the Diagnosis and Prognosis of Emergency Department Patients with Suspected Infections and Suspected Sepsis (“SEPSIS-SHIELD”)
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 20-000222
NCT ID: NCT04094818
Sponsor Protocol Number: INF-04
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:
1. Age >18 year
2. 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: >38 C 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
3. Able to provide informed consent, or consent by legally authorized representative.
Exclusion Criteria:
1. 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).
2. 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.
3. Previously enrolled in the present clinical trial.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 3/10/23. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available