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

NCT ID: NCT03744741

Last Updated: 2021-12-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 585 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-23
• Study Completion Date: 2020-01-20

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

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

Keywords

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

HostDx Sepsis

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Procalcitonin; C-reactive protein; Molecular respiratory pathogen panel

Eligibility Criteria

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:

• 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. 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.

2. Prisoners, mentally disabled, or unable or unwilling to give consent.

3. Previously enrolled in the present clinical trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inflammatix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Emory University

Atlanta, Georgia, United States

University of Kentucky Chandler Medical Center

Lexington, Kentucky, United States

Baystate Medical Center

Springfield, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Texas Tech University Health Sciences Center El Paso

El Paso, Texas, United States

Attikon University Hospital

Chaïdári, , Greece

Countries

United States; Greece

Other Identifiers

OSCCCx-INF-02

Identifier Type: -

Identifier Source: org_study_id