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

NCT03744741 | Completed

• 1 other identifier: OSCCCx-INF-02
• Study Type: observational
• Target: 585
• Locations: 2 countries
• Sites: 7

Brief 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

Keywords

Acute Infections; Host response; mRNA; diagnosis; prognosis; procalcitonin; c-reactive protein; molecular respiratory panel; adults

Outcome Measures

Primary Outcomes (3)

• Concordance of HostDx Sepsis diagnostic test read-out: likelihood of bacterial infection

  Percent agreement of HostDx Sepsis bacterial readout with clinical adjudication by physician 30 days after enrollment for the presence of a bacterial infection

  30 days after enrollment

• Concordance of HostDx Sepsis diagnostic test read-out: likelihood of viral infection

  Percent agreement of HostDx Sepsis viral readout with clinical adjudication by physician 30 days after enrollment for the presence of a viral infection

  30 days after enrollment

• Concordance of HostDx Sepsis prognostic read-out (severity) with patient outcome

  Percent agreement between HostDx Sepsis severity readout and patient outcome, ie mortality, severity of infection, management of patient

  30 days after enrollment

Interventions

HostDx Sepsis DIAGNOSTIC_TEST

Blood collection for mRNA analysis, Procalcitonin and CRP determination, molecular analysis of nasopharyngeal swab collection

Also known as: Procalcitonin, C-reactive protein, Molecular respiratory pathogen panel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the ED with acute infections or suspected sepsis

You may qualify if:

• Age \> 18 year
• 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:
• 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
• Able to provide informed consent, or consent by legally authorized representative.

You may not qualify if:

• Treatment with systemic antibiotics, antiviral agents, or antifungal agents within the past 7 days prior to the emergency department study visit. Participants will not be excluded for the use topical antibiotics, antiviral agents, or antifungal agents.
• Prisoners, mentally disabled, or unable or unwilling to give consent.
• Previously enrolled in the present clinical trial

Sponsors & Collaborators

• Inflammatix: lead

Study Sites (7)

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 16148, United States

Location

Texas Tech University Health Sciences Center El Paso

El Paso, Texas, 79905, United States

Location

Attikon University Hospital

Chaïdári, 12462, Greece

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

PAXgene RNA tubes containing whole blood

MeSH Terms

Conditions

Respiratory Tract Infections; Urinary Tract Infections; Soft Tissue Infections; Intraabdominal Infections; Sepsis; Disease

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2018
• First Posted: November 16, 2018
• Study Start: July 23, 2018
• Primary Completion: November 25, 2019
• Study Completion: January 20, 2020
• Last Updated: December 3, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (6); GR (1)