Assessment of Heparin Binding Protein for the Prediction of Severe Sepsis

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03113721
• Other study ID #: PEP-FMHBP-005
• Status: Active, not recruiting
• 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
• 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:

Related Conditions & MeSH terms

• Sepsis
• Sepsis With Acute Organ Dysfunction
• Septic Shock
• Shock, Septic
• Toxemia

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