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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03474809

Enrollment

296

Registered

2018-03-23

Start date

2018-06-14

Completion date

2019-03-15

Last updated

2019-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Keywords

Sepsis, PSP, Abionic

Brief 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 \[PCT\]).

Interventions

DEVICEBlood 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 \[PCT\]).

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Adult patients (age ≥ 18 years) 2. Requiring ICU management 3. At high risk of sepsis (septic patients are excluded) 4. Expected ICU stay for more than 4 days 5. Have provided written informed consent or consent is given by the patient's legally designated representative.

Exclusion criteria

1. Patient expected to die within 48 hours of admission to ICU 2. Patient suffering from or known acute or chronic pancreatitis, pancreatic cancer or admitted after pancreatectomy, but if a patient develops any pancreatic disease during the IUC stay he/she will remain in the study.

Design outcomes

Primary

Measure	Time frame	Description
Assessment of the performance of serial PSP values measured using the AbioScope.	Day 1 to Day 30, or until discharge from ICU	i) To assess the performance of serial PSP values measured using the AbioScope in the early detection of sepsis in ICU patients at high risk of developing sepsis.

Countries

France, Italy, Switzerland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026