Clinical Trials

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.