Assessment of Heparin Binding Protein for the Prediction of Severe Sepsis

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

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.

Study Overview

• Status: Unknown
• Conditions: Sepsis; Septic Shock; Sepsis With Acute Organ Dysfunction

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.

• Study Type: Observational
• Enrollment (Actual): 571

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Philadelphia, Pennsylvania, United States, 19102
      • Drexel University
    • York, Pennsylvania, United States, 17403
      • York Hospitals
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients (greater than 18 years) presenting to ED with suspected infection

Description

Inclusion Criteria:

• >18 years of age, suspected infection

Exclusion Criteria:

• None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Axis Shield Diagnostics Ltd
• Collaborators: Baylor College of Medicine; Vanderbilt University Medical Center; York Hospitals; Drexel University; Jefferson Medical College of Thomas Jefferson University
• Investigators: Principal Investigator: Theodore Corbin, MD, Drexel University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 27, 2017
• Primary Completion (ACTUAL): December 31, 2018
• Study Completion (ANTICIPATED): March 1, 2019

Study Registration Dates

• First Submitted: March 24, 2017
• First Submitted That Met QC Criteria: April 12, 2017
• First Posted (ACTUAL): April 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 9, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: PEP-FMHBP-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No