CV-SQuISH-ED: Clinical Validation Study

NCT04933760 | Unknown FDA Device

• 1 other identifier: CV-CLN-007
• Study Type: observational
• Target: 599
• Locations: 1 country
• Sites: 4

Brief Summary

This is a study to evaluate the diagnostic performance of the investigational Cytovale System \& IntelliSep Test as a diagnostic marker of sepsis in a population of patients presenting to the emergency department with signs or suspicion of infection compared to retrospective physician adjudication, per the sepsis 3 definition, of those patients.

Conditions

Sepsis; Infection

Keywords

Sepsis

Outcome Measures

Primary Outcomes (1)

• IntelliSep Index versus Retrospective Physician Diagnosis (RPD) per the sepsis 3 definition

  To validate the diagnostic performance of the investigational Cytovale System \& IntelliSep Test as a diagnostic marker of sepsis in a population of patients presenting to the emergency department with signs or suspicion of infection, the IntelliSep test score is compared to the non-reference method of retrospective physician adjudication, per the sepsis 3 definition, of those patients.

  30 days

Interventions

Cytovale IntellipSep test DIAGNOSTIC_TEST

The Cytovale IntelliSep test measures a series of physical properties that indicate activation of leukocytes obtained from a venous K2-EDTA anti-coagulated whole blood sample.

Eligibility Criteria

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

Study Population

Patients presenting to the Emergency Department with signs or suspicion of infection.

You may qualify if:

• ≥ 18 years old
• The first vital sign (any one of: blood pressure, temperature, pulse or respiratory rate) has been recorded in the medical record
• A 300µl blood sample originally collected in a K2 EDTA (hematology purple top) tube within 4 hours of the first recorded vital sign is available.
• Sign or suspicion of infection, defined as meeting either of criterion A-1 and A-2 (based on temperature, WBC, heart rate, respiratory rate and/or culture order criteria):

You may not qualify if:

• Patients in whom a palliative care or hospice course is expected during ED visit
• Self-reported, documented or otherwise known to be actively enrolled on any experimental/investigational therapeutic medication prior to blood collection
• Self-reported, documented, or known history of a hematologic malignancy (any leukemia, lymphoma, or myeloma), myelodysplastic syndrome, or myeloproliferative disorder
• Self-reported, documented or otherwise known to receive a chemotherapeutic agent or other excluded medication in the past 3 months (Appendix C)
• Self-reported, documented or otherwise known to have undergone a hematopoietic stem cell transplant or any solid organ transplant
• Patients transferred to the Emergency Department from another acute care facility
• Residents or patients of a hospital-based skilled nursing facility

Sponsors & Collaborators

• Cytovale, Inc.: lead

Study Sites (4)

Lady of the Lake Regional Medical Center

Baton Rouge, Louisiana, 70808, United States

Location

University of Missouri

Columbia, Missouri, 65212, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Sepsis; Infections

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tonya Jagneaux, MD

  Lady of the Lake Regional Medical Center

  PRINCIPAL INVESTIGATOR

• Hariharan Regunath, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

• Liza Rosenman, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Simon Mahler, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 22, 2021
• Study Start: May 18, 2021
• Primary Completion: January 13, 2022
• Study Completion: May 1, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)