NCT03113721

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
571

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

March 27, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

1.8 years

First QC Date

March 24, 2017

Last Update Submit

January 8, 2019

Conditions

SepsisSeptic ShockSepsis With Acute Organ Dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \>18 years of age, suspected infection

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Drexel University

Philadelphia, Pennsylvania, 19102, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

York Hospitals

York, Pennsylvania, 17403, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Human plasma

MeSH Terms

Conditions

SepsisShock, Septic

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Theodore Corbin, MD

    Drexel University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2017

First Posted

April 13, 2017

Study Start

March 27, 2017

Primary Completion

December 31, 2018

Study Completion

March 1, 2019

Last Updated

January 9, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(5)