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

Sepsis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03474809
• Other study ID #: AB-PSP-001
• Status: Completed
• Start date: June 14, 2018
• Est. completion date: March 15, 2019

Study information

• Verified date: August 2019
• Source: Abionic SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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]).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: March 15, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

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]).

Locations

Country	Name	City	State
France	CH Le Mans, Service de Réanimation Médico Chirurgicale & USC	Le Mans
France	CHU Limoges, Réanimation Polyvalente	Limoges
France	CH Lyon-Sud, Services de soins critiques	Pierre-Bénite
France	Hôpital Bretonneau, CHU de Tours, Médecine Intensive - Réanimation	Tours
Italy	Ospedale Santa Maria della Misericordia, Terapia Intensiva	Perugia
Italy	Ospedale Santa Maria delle Croci, Terapia Intensiva	Ravenna
Italy	Ospedale Infermi, Dept Anesthesia and ICU	Rimini
Italy	Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione	Torino
Switzerland	Bern University Hospital, Universitätsklinik für Intensivmedizin	Bern
Switzerland	Hopitaux Universitaires de Genève, Service des soins intensifs, Département APSI	Geneva
Switzerland	Centre Hospitalier Universitaire Vaudois, Service of Adult Intensive Care	Lausanne
United Kingdom	Royal Surrey County Hospital, Intensive Care Medicine	Guildford
United Kingdom	Guy's & St Thomas' Hospital, Department of Critical Care	London
United Kingdom	University College London Hospitals, Anaesthetics Department	London

Sponsors (1)

Lead Sponsor	Collaborator
Abionic SA

Countries where clinical trial is conducted

France,  Italy,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the performance of serial PSP values measured using the AbioScope.	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.	Day 1 to Day 30, or until discharge from ICU