CV-SQuISH-ED: Clinical Validation Study

• Sponsor: Cytovale, Inc. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04933760
• Collaborator: (none)
• Enrollment: 599
• Locations: 4
• Anticipated Duration (Months): 11.4
• Patients Per Site: 149.8
• Patients Per Site Per Month: 13.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis; Infection	Diagnostic Test: Cytovale IntellipSep test

Detailed Description

This is a multi-site prospective study to evaluate the diagnostic performance of the investigational Cytovale System & IntelliSep Test for patients presenting to the Emergency Department with signs or suspicion of infection. The IntelliSep Test is a microfluidic test that measures the biophysical properties of human leukocytes in conjunction with other laboratory findings and clinical assessments to aid in the early detection of sepsis with organ dysfunction occurring within the first three days after the blood sample collection.

Study Design

• Study Type: Observational
• Actual Enrollment: 599 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: CV-SQuISH-ED: A Clinical Validation Solving the Question of Inflammation or Sepsis Hastily in the Emergency Department
• Actual Study Start Date: May 18, 2021
• Actual Primary Completion Date: Jan 13, 2022
• Anticipated Study Completion Date: May 1, 2022

Outcome Measures

Primary Outcome Measures

1. IntelliSep Index versus Retrospective Physician Diagnosis (RPD) per the sepsis 3 definition [30 days]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. ≥ 18 years old

2. The first vital sign (any one of: blood pressure, temperature, pulse or respiratory rate) has been recorded in the medical record

3. 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.

4. 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):

Exclusion Criteria:

1. Patients in whom a palliative care or hospice course is expected during ED visit

2. Self-reported, documented or otherwise known to be actively enrolled on any experimental/investigational therapeutic medication prior to blood collection

3. Self-reported, documented, or known history of a hematologic malignancy (any leukemia, lymphoma, or myeloma), myelodysplastic syndrome, or myeloproliferative disorder

4. Self-reported, documented or otherwise known to receive a chemotherapeutic agent or other excluded medication in the past 3 months (Appendix C)

5. Self-reported, documented or otherwise known to have undergone a hematopoietic stem cell transplant or any solid organ transplant

6. Patients transferred to the Emergency Department from another acute care facility

7. Residents or patients of a hospital-based skilled nursing facility

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lady of the Lake Regional Medical Center	Baton Rouge	Louisiana	United States	70808
2	University of Missouri	Columbia	Missouri	United States	65212
3	Wake Forest Baptist Health	Winston-Salem	North Carolina	United States	27157
4	University of Washington	Seattle	Washington	United States	98104

Sponsors and Collaborators

• Cytovale, Inc.

Investigators

• Principal Investigator: 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cytovale, Inc.
• ClinicalTrials.gov Identifier: NCT04933760
• Other Study ID Numbers: CV-CLN-007
• First Posted: Jun 22, 2021
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Cytovale, Inc.: Sepsis
• Additional relevant MeSH terms: Sepsis

Study Results

No Results Posted as of Mar 31, 2022