NCT02704871

The Ward Study for SeptiCyte® Lab to Distinguish Between Infection-positive and Infection-negative SIRS

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 66 (actual)
• Sponsor: Immunexpress · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Sepsis
• SIRS

Interventions

Type	Name	Description
OTHER	SeptiCyte Lab molecular diagnostic test (non-interventional)	This is not an interventional study. Rather it involves evaluation of a molecular diagnostic test to distinguish between sepsis and infection-negative SIRS based on host response.

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-04-01
• Completion: 2018-02-01
• First posted: 2016-03-10
• Last updated: 2018-03-01

Locations

1 site across 1 country: United States