NCT03474809

Early Diagnostic of Sepsis and Potential Impact on Antibiotic Management Based on Serial.Pancreatic Stone Protein (PSP) Measured Using the AbioScope.

A Multicenter, Device Clinical Study for the Early Diagnostic of Sepsis and Potential Impact on Antibiotic Management Based on Serial Pancreatic Stone Protein (PSP) Measured Using the AbioScope in Critically Ill Patients at High Risk of Sepsis.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 296 (actual)
• Sponsor: Abionic SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to compare the early detection of sepsis and the decision, by the Investigator to start or not, or to change, antibiotics in Intensive Care Unit (ICU) patients at high risk of sepsis, based on standard of care (clinical, laboratory and imaging data but not on PSP values), as well as timing of antibiotic de-escalation versus the the retrospective assessment (i.e., at the end of the study) of a First Endpoint Adjudication Committee (EAC) which is aware of the clinical data and of the PSP values but not of the Investigator's decision(s), and of the retrospective assessment of a Second Endpoint Adjudication Committee which is only aware of the PSP values. This study will follow the site's routine clinical practice for the diagnostic, assessment and treatment of the enrolled patients, with the exception of daily blood samples which will be taken for the PSP measurement using the AbioScope as well as another daily sample taken for central analysis of biomarkers of inflammation, infection and/or sepsis (including but not limited to C-reactive protein \[CRP\] and Procalcitonin \[PCT\]).

Conditions

• Sepsis

Interventions

Type	Name	Description
DEVICE	Blood sampling	Daily blood samples which will be taken for the PSP measurement using the AbioScope as well as another daily sample taken for central analysis of biomarkers of inflammation, infection and/or sepsis (including but not limited to C-reactive protein \[CRP\] and Procalcitonin \[PCT\]).

Timeline

• Start date: 2018-06-14
• Primary completion: 2019-03-15
• Completion: 2019-03-15
• First posted: 2018-03-23
• Last updated: 2019-08-13

Locations

14 sites across 4 countries: France, Italy, Switzerland, United Kingdom