Early Diagnostic of Sepsis and Potential Impact on Antibiotic Management Based on Serial.Pancreatic Stone Protein (PSP) Measured Using the AbioScope.
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|ClinicalTrials.gov Identifier: NCT03474809|
Recruitment Status : Completed
First Posted : March 23, 2018
Last Update Posted : August 13, 2019
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]).
|Condition or disease||Intervention/treatment|
|Sepsis||Device: Blood sampling|
|Study Type :||Observational|
|Actual Enrollment :||296 participants|
|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.|
|Actual Study Start Date :||June 14, 2018|
|Actual Primary Completion Date :||March 15, 2019|
|Actual Study Completion Date :||March 15, 2019|
- 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]).
- Assessment of the performance of serial PSP values measured using the AbioScope. [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03474809
|CH Le Mans, Service de Réanimation Médico Chirurgicale & USC|
|Le Mans, France, 72037|
|CHU Limoges, Réanimation Polyvalente|
|Limoges, France, 87042|
|CH Lyon-Sud, Services de soins critiques|
|Pierre-Bénite, France, 69495|
|Hôpital Bretonneau, CHU de Tours, Médecine Intensive - Réanimation|
|Tours, France, 37044|
|Ospedale Santa Maria della Misericordia, Terapia Intensiva|
|Perugia, Italy, 6156|
|Ospedale Santa Maria delle Croci, Terapia Intensiva|
|Ravenna, Italy, 48121|
|Ospedale Infermi, Dept Anesthesia and ICU|
|Rimini, Italy, 47921|
|Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione|
|Torino, Italy, 10154|
|Bern University Hospital, Universitätsklinik für Intensivmedizin|
|Bern, Switzerland, 3010|
|Hopitaux Universitaires de Genève, Service des soins intensifs, Département APSI|
|Geneva, Switzerland, 1205|
|Centre Hospitalier Universitaire Vaudois, Service of Adult Intensive Care|
|Lausanne, Switzerland, 1011|
|Royal Surrey County Hospital, Intensive Care Medicine|
|Guildford, United Kingdom, GU2 7XX|
|University College London Hospitals, Anaesthetics Department|
|London, United Kingdom, NW1 2BU|
|Guy's & St Thomas' Hospital, Department of Critical Care|
|London, United Kingdom, SE1 7EH|