SepsisNCT04933760
CV-SQuISH-ED: Clinical Validation Study
An observational study of Sepsis and Infection, run by Cytovale, Inc. at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Cytovale IntellipSep test
- How many people
- 599 participants
- Where
- 4 sitesUnited States
- Study dates
- 18 May 2021to 1 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to the Emergency Department with signs or suspicion of infection.
Who may be able to join
- ≥ 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):
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, 70808
University of Missouri
Columbia, Missouri, 65212
University of Washington
Seattle, Washington, 98104
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: CV-SQuISH-ED: A Clinical Validation Solving the Question of Inflammation or Sepsis Hastily in the Emergency Department
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.
Read the 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.
- Being tested
- Cytovale IntellipSep test
- Keywords
- Sepsis
- Medical subject headings
- Sepsis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytovale IntellipSep testDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start18 May 2021
- Primary completion13 Jan 2022
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 599 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytovale, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tonya Jagneaux, MD, Principal investigator, Lady of the Lake Regional Medical CenterHariharan Regunath, MD, Principal investigator, University of Missouri-ColumbiaLiza Rosenman, MD, Principal investigator, University of WashingtonSimon Mahler, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933760
- Sponsor's protocol ID
- CV-CLN-007
- Status last verified
- Mar 2022
- First submitted
- 14 Jun 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CV-SQuISH-ED: A Clinical Validation Solving the Question of Inflammation or Sepsis Hastily in the Emergency Department
- ClinicalTrials.gov ID
- NCT04933760
- Acronym / sponsor ID
- CV-CLN-007
- Keywords
- Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 599 participants (actual)
- Lead sponsor
- Cytovale, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 May 2021 (actual)
- Primary completion
- 13 Jan 2022 (actual)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 22 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the Emergency Department with signs or suspicion of infection.
Key inclusion criteria (4 listed)
- ≥ 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):
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytovale IntellipSep testThe 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. | Diagnostic test | – |
Primary outcome
IntelliSep Index versus Retrospective Physician Diagnosis (RPD) per the sepsis 3 definition
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tonya Jagneaux, MD principal investigator
Lady of the Lake Regional Medical Center
Hariharan Regunath, MD principal investigator
University of Missouri-Columbia
Liza Rosenman, MD principal investigator
University of Washington
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Infection, run by Cytovale, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IntelliSep Index versus Retrospective Physician Diagnosis (RPD) per the sepsis 3 definition (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.