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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03113721
Other study ID # PEP-FMHBP-005
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 27, 2017
Est. completion date March 1, 2019

Study information

Verified date January 2019
Source Axis Shield Diagnostics Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 571
Est. completion date March 1, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- >18 years of age, suspected infection

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Baylor College of Medicine Houston Texas
United States Vanderbilt University Medical Center Nashville Tennessee
United States Drexel University Philadelphia Pennsylvania
United States Thomas Jefferson University Philadelphia Pennsylvania
United States York Hospitals York Pennsylvania

Sponsors (6)

Lead Sponsor Collaborator
Axis Shield Diagnostics Ltd Baylor College of Medicine, Drexel University, Jefferson Medical College of Thomas Jefferson University, Vanderbilt University Medical Center, York Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of plasma levels of HBP to evaluate patients with suspected infection for their risk of developing severe sepsis 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. 72 hours
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