NCT02424721

Brief Summary

To validate the use of the Heparin Binding Protein (HBP) concentration to assist in the evaluation of patients admitting to the emergency department with suspected infection.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2015

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
terminated

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

April 15, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 23, 2015

Completed
8 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

3.6 years

First QC Date

April 15, 2015

Last Update Submit

January 8, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Validation of use of HBP in evaluation of patients with suspected infection

    12 months

Eligibility Criteria

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

Patients presenting to the Emergency Department with suspected infection

You may qualify if:

  • \>18 years of age,
  • Suspected infection (temperature \>38C or clinical evidence of infection),
  • intention by clinician to start antibiotics

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Clinique St Anne St Remy

Anderlecht, 1070, Belgium

Location

Hopital Erasme

Brussels, 1070, Belgium

Location

Hopital Civil de Charleroi

Charleroi, 6000, Belgium

Location

CHU Tivoli

La Louvière, 7100, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma - NaCitrate and LiHep

MeSH Terms

Conditions

SepsisShock, Septic

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Jean-Louis Vincent, MD

    Erasme University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 15, 2015

First Posted

April 23, 2015

Study Start

May 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

January 9, 2019

Record last verified: 2019-01

Locations