Sepsis Clinical Trial
Official title:
To Assess the Performance of SeptiCyte® Lab to Diagnose Patients Identified as Suspected of Sepsis in General Medical and Surgical Wards With Infection-positive From Infection-negative SIRS
A non-interventional, prospective observational study to assess the performance of SeptiCyte® Lab to diagnose patients identified as suspected of sepsis in general medical and surgical wards with infection-positive from infection-negative SIRS
This study is evaluating a molecular diagnostic device developed to distinguish between
sepsis and infection-negative SIRS among critically ill patients.
This study is a prospective, non-randomized, non-interventional, observational trial of
patients with suspected sepsis in the medical and/or surgical wards. The study is being
conducted on two preselected patient care units.
All patients identified by a local screening tool undergo physician review. If the suspicion
of sepsis is found to be plausible, routine and conventional diagnostic procedures,
including: routine bloods, blood culture and specialized tests are conducted.
Blood collection for SeptiCyte® Lab and SeptID® is drawn within 6 hours of a positive screen
- both use peripheral blood as the clinical sample. The diagnostic performance of the two
experimental assays will be compared to Retrospective Physician Diagnosis (RPD), and
conventional microbiological culture. The results of SeptiCyte® Lab and SeptID® are not used
in any clinical decision-making.
This data will be used to analyze the performance of SeptiCyte® Lab according to the endpoint
measures.
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