Prospective, Non-interventional, Multi-centre Clinical Study to Assess the Clinical Validity of the HBP Assay to Predict Development of Severe Sepsis in Patients With Suspected Infection Following ED Admission
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Sepsis
- Sponsor
- Axis Shield Diagnostics Ltd
- Enrollment
- 571
- Locations
- 5
- Primary Endpoint
- Measurement of plasma levels of HBP to evaluate patients with suspected infection for their risk of developing severe sepsis
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this prospective, non-interventional, multi-centre clinical study is to assess the clinical validity of the Heparin Binding Protein (HBP) assay for indicating the presence, or outcome, of severe sepsis (including septic shock), over 72 hours, in patients with suspected infection following emergency department admission.
Detailed Description
The primary objective of this study is to use HBP concentration to indicate the presence, or outcome, of severe sepsis (including septic shock) at admission and to predict the outcome of severe sepsis (including septic shock) over 72 hours, in patients with suspected infection following emergency department admission. The secondary objectives of this study are to separately evaluate the performance of HBP concentration to a) indicate the presence of severe sepsis (including severe sepsis) at admission and b) to predict the outcome of severe sepsis (including septic shock) over 72 hours, in patients with suspected infection following emergency department admission. Further exploratory objectives include evaluating the use of HBP measurement to indicate the outcome of severe sepsis (including septic shock) in patients with suspected infection 12-24 hours after emergency department admission, to compare the use of HBP to other markers of severe infection and to evaluate whether or not different cut-off values are required for the progression and outcome measures.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\>18 years of age, suspected infection
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Measurement of plasma levels of HBP to evaluate patients with suspected infection for their risk of developing severe sepsis
Time Frame: 72 hours
The purpose of this measurement is to assess the clinical validity of plasma levels of HBP for indicating the presence, or outcome, of severe sepsis (including septic shock), over 72 hours, in patients with suspected infection following emergency department admission. The concentration of plasma HBP will be compared to the final clinical outcome of the patient to assess the ability of the HBP level to predict clinical progression.