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

Completed

• Conditions: Sepsis

• Registration Number: NCT03474809
• Lead Sponsor: Abionic SA

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 \[PCT\]).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-16
• Study First Submitted QC: 2018-03-16
• Study First Posted: 2018-03-23
• Study Start: 2018-06-14
• Primary Completion: 2019-03-15
• Study Completion: 2019-03-15
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 296

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (14)

Centre Hospitalier Universitaire Vaudois, Service of Adult Intensive Care; 🇨🇭 Lausanne, Switzerland

Hopitaux Universitaires de Genève, Service des soins intensifs, Département APSI; 🇨🇭 Geneva, Switzerland

CHU Limoges, Réanimation Polyvalente; 🇫🇷 Limoges, France

CH Le Mans, Service de Réanimation Médico Chirurgicale & USC; 🇫🇷 Le Mans, France

CH Lyon-Sud, Services de soins critiques; 🇫🇷 Pierre-Bénite, France

Hôpital Bretonneau, CHU de Tours, Médecine Intensive - Réanimation; 🇫🇷 Tours, France

Ospedale Santa Maria delle Croci, Terapia Intensiva; 🇮🇹 Ravenna, Italy

Ospedale Santa Maria della Misericordia, Terapia Intensiva; 🇮🇹 Perugia, Italy

Ospedale Infermi, Dept Anesthesia and ICU; 🇮🇹 Rimini, Italy

Bern University Hospital, Universitätsklinik für Intensivmedizin; 🇨🇭 Bern, Switzerland

Royal Surrey County Hospital, Intensive Care Medicine; 🇬🇧 Guildford, United Kingdom

University College London Hospitals, Anaesthetics Department; 🇬🇧 London, United Kingdom

Guy's & St Thomas' Hospital, Department of Critical Care; 🇬🇧 London, United Kingdom

Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione; 🇮🇹 Torino, Italy