NCT03744741

HostDx Sepsis in the Diagnosis and Prognosis of Emergency Department Patients With Suspected Infections: a Multicenter Pilot Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 585 (actual)
• Sponsor: Inflammatix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Subjects presenting to the emergency department with a suspected acute infection will be eligible. Suspected infections may be of a) respiratory, b) urinary, c) intra-abdominal, or d) skin \& soft tissue etiology. Subjects with suspected sepsis of any cause will also be eligible. Blood sample collections: Clinical study staff or the treating physician will obtain patient consent and collect two PAXgene RNA tubes of whole blood by venipuncture. The blood samples will be stored at room temperature overnight prior to being frozen at -80C for long-term storage. Samples will be shipped to the sponsor for testing using the HostDx Sepsis test. An additional tube of blood obtained via venipuncture and stored for shipment to a centralized testing laboratory, where it will be tested for C-reactive protein and procalcitonin. This will be done for all participants, even if they had these tests ordered locally as SOC. In participants with suspected respiratory tract infections a nasopharyngeal swab will be collected as intervention and sent to the reference laboratory. The sample will be processed in a respiratory pathogen panel (regardless of whether the participants had or had not provided a nasopharyngeal swab for local testing with a respiratory panel as SOC). Results obtained from microbiological testing of the following additional samples will be recorded if testing had been performed locally as SOC: 1. Suspected urinary tract infection: Urine sample for culture. 2. Suspected skin \& soft tissue infection: Swab from wound or abscess drainage, or other sample, for culture. 3. Suspected intra-abdominal infection or abscesses (e.g. appendicitis, diverticulitis, cholecystitis): Swab, biopsy or other sample types for culture 4. Suspected sepsis of any cause: blood cultures (at least 1 set following local guidelines). 5. Suspected respiratory tract infection: sputum culture and/or throat culture.

Conditions

• Respiratory Tract Infections
• Urinary Tract Infections
• Skin and Soft Tissue Infections
• Intraabdominal Infections
• Sepsis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	HostDx Sepsis	Blood collection for mRNA analysis, Procalcitonin and CRP determination, molecular analysis of nasopharyngeal swab collection

Timeline

• Start date: 2018-07-23
• Primary completion: 2019-11-25
• Completion: 2020-01-20
• First posted: 2018-11-16
• Last updated: 2021-12-03

Locations

7 sites across 2 countries: United States, Greece