Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
300 participants
OBSERVATIONAL
2020-04-07
2022-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
CV-SQuISH-ED: Clinical Validation Study
NCT04933760
HostDx Sepsis in the Diagnosis and Prognosis of Emergency Department Patients With Suspected Infections: a Multicenter Pilot Study
NCT03744741
Safety and Efficacy of SCD in AKI or ARDS Patients Associated With COVID-19 Infections
NCT04395911
The Ward Study for SeptiCyte® Lab to Distinguish Between Infection-positive and Infection-negative SIRS
NCT02704871
SEPSIS 3 Critera for Risk Stratification in Emergency Patients
NCT02738164
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. ≥ 18 years old or older
2. The first vital sign (any one of: blood pressure, temperature, pulse or respiratory rate) has been recorded in the medical record
3. A complete blood count has been ordered for which a blood sample has been collected within 4.5 hours since the first vital sign was recorded
4. Signs or suspicion of a respiratory infection, defined as:
1. Subject designated for evaluation in the ED respiratory or pulmonary pod or similar location. OR
2. An order placed for a respiratory viral panel. OR
3. An order placed for a SARS-CoV-2 test. OR
4. A subject self-reported as having tested positive for the SARS-CoV-2 test within the previous 7 days and returning with a related complaint.
Exclusion Criteria
a. Blood sample volume is \< 300 ul; insufficient quantity for SeptiScan testing.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biomedical Advanced Research and Development Authority
FED
Cytovale, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hollis R O'Neal, Jr., MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Pulmonary & Critical Care LSUHSC, Baton Rouge
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CV-CLN-003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.