Hemospec Device for Sepsis Diagnosis (INTELLIGENCE)
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|ClinicalTrials.gov Identifier: NCT03350113|
Recruitment Status : Completed
First Posted : November 22, 2017
Last Update Posted : May 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Sepsis||Device: Blood sampling for analysis||Not Applicable|
Sepsis is a life-threating organ dysfunction resulting from the dysregulated response of the host to an infection. It is estimated that 1.5 million people present with sepsis annually in Northern America and another 1.5 million people in Europe; 30 to 50% of them die making sepsis the leading cause of death. The key-point in the management of sepsis is the early resuscitation with broad- spectrum antimicrobials and intravenous fluids, if possible within the first hour. However, it is not easy to achieve this goal, especially among patients assessed in the Emergency Department (ED), as the diagnosis of an infection is often delayed until the patient's laboratory and imaging tests are completed.
In an attempt to improve the failure of physicians for early sepsis recognition in the ED, several markers have been developed. The most widely used biomarkers are the absolute number of neutrophils, C-reactive protein (CRP) and procalcitonin (PCT). HemoSpec is a device capable of incorporating clinical information from the patient with laboratory data. The analysis provides information on white blood cell morphology, CRP, PCT, interleukin (IL) -6 and suPAR. The device software has been created from all of the above information collected from prospective cohorts of patients from Greece and Germany. The diagnostic function of HemoSpec has so far been validated in two Phase II studies. The first study took place in Germany and involved 60 patients (20 controls, 20 with systemic inflammatory response and 20 with sepsis) who were hospitalized at the University Hospital in Jena. The second study is currently being conducted in Greece and aims to use the information from the HemoSpec device for the prospective categorization of patients with confirmed infection in patients with sepsis and in patients without sepsis.
The above two studies share a common Phase II design in order to validate HemoSpec's diagnostic ability among patients who are clinically diagnosed with sepsis. The clinical reliability of HemoSpec can be verified in a multicenter prospective trial involving patients assessed in the ED. The present study aims to assess the diagnostic ability of the device in ED patients with clinical signs of infection who have a significant risk of death that makes them likely to suffer from sepsis.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||129 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Integration of Clinical and Laboratory Information to Generate Technological Advance for the Diagnosis of Sepsis - The Intelligence 2 Trial|
|Actual Study Start Date :||October 2, 2017|
|Actual Primary Completion Date :||April 30, 2018|
|Actual Study Completion Date :||April 30, 2018|
Blood Sampling for analysis in the HemoSpec device
Device: Blood sampling for analysis
Blood Sampling for Analysis
Other Name: Hemospec
- Sensitivity of HemoSpec for the diagnosis of sepsis [ Time Frame: 4 days ]The sensitivity of HemoSpec output to diagnose the presence of sepsis compared to the absence of sepsis. HemoSpec output will be considered to provide a satisfactory diagnosis of sepsis if sensitivity for the diagnosis is greater than 90%.
- Diagnostic performance for sepsis [ Time Frame: 4 days ]The diagnostic performance of HemoSpec output to diagnose the presence of sepsis compared to the absence of sepsis. The diagnostic performance is composed by the aggregation of specificity, positive predictive value and negative predictive value.
- Prognostics performance for sepsis [ Time Frame: 28 days ]The prognostic performance of HemoSpec output to predict unfavorable outcome compared to survivors. The prognostic performance is composed by the aggregation of sensitivity, specificity, positive predictive value and negative predictive value.
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): NCT03350113
|Univeristy of Jena|
|Jena, Germany, 07743|
|General Hospital of Lamia|
|Lamia, Phthiotis, Greece, 35100|
|4th Department of Internal Medicine, ATTIKON University Hospital|
|Athens, Greece, 12462|
|Study Chair:||Evangelos J Giamarellos-Bourboulis, MD, PhD||National and Kapodistrian University of Athens|
|Principal Investigator:||Magdalini Bristianou, MD, PhD||General Hospital of Lamia|
|Principal Investigator:||Michael Bauer, MD, PhD||Jena University Hospital|