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Purpose

This study will analyze gene expression and other laboratory data from biological samples collected from participants with suspected respiratory, urinary, intra-abdominal, and/or skin & soft tissue infections; or suspected sepsis of any cause.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Age >18 year
  2. 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:
  3. Heart rate: >90 beats/ minute
  4. Temperature: >38 C or <36C
  5. Respiratory Rate: >20 breaths / minutes or PaO2 of <60 mmHg or SpO2 <90%
  6. Systolic blood pressure: <100 mmHg
  7. Altered mental status: Per clinical exam
  8. 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:
  2. Use of topical antibiotics, topical antiviral or topical antifungal agents
  3. Use of peri-operative (prophylactic) antibiotics
  4. Use of a single dose of antibiotics during the present ED visit (<6h before blood draw).
  5. 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.
  6. Previously enrolled in the present clinical trial.

Study Design

Phase
Study Type
Observational
Observational Model
Case-Control
Time Perspective
Prospective

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40536
Contact:
Theresa Mims
859-218-5540
theresa.mims@uky.edu

More Details

NCT ID
NCT04094818
Status
Recruiting
Sponsor
Inflammatix

Study Contact

Oliver Liesenfeld, MD
(650) 443-3030
clinicaltrials@inflammatix.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.