Sepsis Assessment in Belgian Emergency Rooms

Sepsis Clinical Trial

— SABER  

Official title:

Prospective, Non-interventional, Multi-centre Clinical Study to Assess the Clinical Validity of the Heparin Binding Protein Assay to Assist in Evaluation of Patients With Suspected Infection Following Emergency Department Admission

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02424721
• Other study ID #: PEP-FMHBP-003
• Status: Terminated
• Start date: May 2015
• Est. completion date: December 2018

Study information

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

Clinical Trial 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.

Description:

Prospective, non-interventional, multi-centre clinical study to assess the clinical validity of the Heparin Binding Protein (HBP) assay to assist in evaluation of patients with suspected infection following emergency department admission.

Patients presenting to the emergency department with suspected infection will be enrolled to the study and have a blood sample taken.

The patients clinical data over a 72 hour period after enrolment will be recorded in the CRF. The enrolment sample will then be retrospectively measured for the HBP level and the power of the enrolment HBP level to predict subsequent clinical development over the following 72 hours will be assessed. Data analysis shall include Area Under Curve (AUC) from Receiver Operating Characteristics (ROC) plot against the patient's final clinical diagnosis as well as sensitivity and specificity of the HBP level to predict the final clinical outcome.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• >18 years of age,

• Suspected infection (temperature >38C or clinical evidence of infection),

• intention by clinician to start antibiotics

Exclusion Criteria:

Related Conditions & MeSH terms

• Emergencies
• Sepsis
• Severe Sepsis
• Shock, Septic
• Toxemia

Locations

Country	Name	City	State
Belgium	Clinique St Anne St Remy	Anderlecht
Belgium	Hopital Erasme	Brussels
Belgium	Hopital Civil de Charleroi	Charleroi
Belgium	CHU Tivoli	La Louviere

Sponsors (1)

Lead Sponsor	Collaborator
Axis Shield Diagnostics Ltd

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of use of HBP in evaluation of patients with suspected infection		12 months