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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
General Hospital of Lamia
University of Jena
Information provided by (Responsible Party):
Evangelos J. Giamarellos-Bourboulis, M.D., University of Athens

Brief Summary:
A diagnostic devise, namely HemoSpec, had been developed that integrates clinical information, along with information on circulating protein biomarkers and the morphology of white blood cells to achieve early diagnosis of sepsis. The current study is aiming to validate and improve performance of HemoSpec for the rapid assessment of the critically ill patient in the Emergency Department.

Condition or disease Intervention/treatment Phase
Sepsis Device: Blood sampling for analysis Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arm Intervention/treatment
Experimental: HemoSpec
Blood Sampling for analysis in the HemoSpec device
Device: Blood sampling for analysis
Blood Sampling for Analysis
Other Name: Hemospec

Primary Outcome Measures :
  1. 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%.

Secondary Outcome Measures :
  1. 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.

  2. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Admission in the Emergency Department
  • Age above or equal to 18 years old
  • Both genders
  • Written consent provided from patients or their first-degree relatives for patients unable to consent
  • Considerable risk of death as indicated by the presence of at least one of the following: i) sudden alteration of mental status; ii) systolic blood pressure less than 100 mmHg; and iii) high respiratory rate defined as more than or equal to 22 breaths per minute.

Exclusion Criteria:

  • Known infection by the human immunodeficiency virus-1
  • Acute myocardial infarction as evidenced by the electrocardiographic finding of ST- elevation.
  • Single trauma or multiple injuries
  • Known pregnancy and breastfeeding
  • Patients with a life expectancy of less than 28 days and with limited treatment options

Information from the National Library of Medicine

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

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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
Sponsors and Collaborators
University of Athens
General Hospital of Lamia
University of Jena
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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
Publications of Results:
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Responsible Party: Evangelos J. Giamarellos-Bourboulis, M.D., Associate Professor of Internal Medicine, University of Athens
ClinicalTrials.gov Identifier: NCT03350113    
Other Study ID Numbers: INTELLIGENCE2
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Evangelos J. Giamarellos-Bourboulis, M.D., University of Athens:
Additional relevant MeSH terms:
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Pathologic Processes
Systemic Inflammatory Response Syndrome