HostDx Sepsis in the Diagnosis and Prognosis of Emergency Department Patients With Suspected Infections: a Multicenter Pilot Study
NCT03744741 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 585
Last updated 2021-12-03
Summary
This study will analyze gene expression data (HostDx Sepsis test) from blood samples collected from participants with suspected infections. The primary endpoint of the study is to prospectively validate the HostDx Sepsis test for infections. As a secondary endpoint the correlation of participant prognosis and gene expression results in the HostDx Sepsis test will be validated. Participants presenting to the emergency departments of enrolling sites with a suspected infection and 1 vital signs OR suspected sepsis and 2 vital sign changes as stated in the protocol are meeting enrollment criteria
Conditions
- Respiratory Tract Infections
- Urinary Tract Infections
- Skin and Soft Tissue Infections
- Intraabdominal Infections
- Sepsis
Interventions
- DIAGNOSTIC_TEST
-
HostDx Sepsis
Blood collection for mRNA analysis, Procalcitonin and CRP determination, molecular analysis of nasopharyngeal swab collection
Sponsors & Collaborators
-
Inflammatix
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-07-23
- Primary Completion
- 2019-11-25
- Completion
- 2020-01-20
Countries
- United States
- Greece
Study Locations
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