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Fast Assay for Pathogen Identification and Characterization (FAPIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03841162
Recruitment Status : Completed
First Posted : February 15, 2019
Last Update Posted : April 29, 2020
Sponsor:
Collaborators:
Jessa Hospital
University of Zagreb
Molzym
AIT Austrian Institute of Technology GmbH
BEE Robotics
University of Warwick
Claude Bernard University
Axo Science
Information provided by (Responsible Party):
prof. dr. Inge Gyssens, Radboud University

Brief Summary:

Sepsis is a life-threatening disease caused by a dysregulated host response to infection. This can lead to organ-dysfunction and septic shock, which is a subset of sepsis where underlying abnormalities increase mortality remarkably. Blood cultures are the gold standard for identifying pathogens in the bloodstream (bacteremia). It is based on cultivation techniques which, theoretically, can detect a single pathogenic cell from a patient sample. However, blood cultures have serious limitations, such as long time to result (3-7 days). This leads to the fact that only a small fraction of the patients obtain a correct diagnosis and in further consequence get the optimal antimicrobial treatment. Patients with sepsis should get antimicrobial treatment within the hour. Thus, physicians start treatment empirically, with broad-spectrum antibiotics. This puts a selective pressure on pathogens and has led to an increased amount of antibiotic resistance. Faster diagnostics are necessary to ensure an immediate and targeted treatment. In the EU-funded FAPIC project, two diagnostic systems that can be used with direct sample material from patients will be developed, avoiding the time-consuming cultivation of pathogens.

In this study, the evaluation of the rapid diagnostics will be performed in patients with sepsis, suspected of bacteremia. To this aim, the performance of the diagnostic systems will be evaluated using blood samples that are collected in parallel with blood cultures. In addition, clinical data of the patients will be collected. In routine care, two blood culture sets (2x2 bottles) per patient are collected. One extra blood samples (EDTA, 9 ml) will be sampled with each blood culture set, totaling 2 samples per patient. In this study, patients presenting at the Emergency Department (ED), and the department of infectious diseases/nephrology will be included. The results will be used to estimate the performance, sensitivity, and specificity of the diagnostic systems compared to blood culture. Furthermore, in order to determine the severity of sepsis and to describe the patient population, clinically relevant parameters and laboratory parameters (ferritin, HLA-DR, serum lactate, SOFA score) will be assessed to determine its association with severity of disease and patient mortality. Evaluation will be done exclusively in the lab, and will not be used directly for the diagnosis or management of patients. Standard care will still be provided.


Condition or disease
Bacteremia Sepsis Septic Shock

Detailed Description:
This study is a follow-up study of the first prospective study performed in 2017 in the same hospital. The ClinicalTrials.gov ID number of the previous study was NCT03025802.

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Study Type : Observational
Actual Enrollment : 1957 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fast Assay for Pathogen Identification and Characterization - Prospective Observational Study
Actual Study Start Date : February 12, 2019
Actual Primary Completion Date : April 17, 2020
Actual Study Completion Date : April 17, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Group/Cohort
Patients with suspected sepsis
Patients for whom blood cultures are drawn at the Emergency Department or the department of Infectious Diseases/Nephrology



Primary Outcome Measures :
  1. Confirmed bacteremia based on positive blood cultures (SOFA score) [ Time Frame: 7 days ]

    Differences in SOFA score between patients with positive blood cultures and patients with negative blood cultures.

    SOFA: Sequential Organ Failure Assessment; Range 0-4 (better to worse).


  2. Confirmed bacteremia based on positive blood cultures (Serum Lactate) [ Time Frame: 7 days ]
    Differences in Serum Lactate levels between patients with positive blood cultures and patients with negative blood cultures

  3. Confirmed bacteremia based on positive blood cultures (Ferritin) [ Time Frame: 7 days ]
    Differences in Ferritin levels between patients with positive blood cultures and patients with negative blood cultures

  4. Test performance [ Time Frame: 1 year ]
    Performance characteristics (Clinical sensitivity, specificity and accuracy) of a new rapid diagnostic systems


Secondary Outcome Measures :
  1. Length of Stay (SOFA score) [ Time Frame: 1 year ]
    Differences in length of stay between patients with high and with low SOFA score SOFA: Sequential Organ Failure Assessment; Range 0-4 (better to worse).

  2. Length of Stay (Serum Lactate) [ Time Frame: 1 year ]
    Differences in length of stay between patients with high and with low Serum Lactate levels

  3. Length of Stay (Ferritin) [ Time Frame: 1 year ]
    Differences in length of stay between patients with high and with low Ferritin levels

  4. 30-day Mortality (Sofa score) [ Time Frame: 30 days ]
    Differences in 30-day mortality between patients with high and with low SOFA score SOFA: Sequential Organ Failure Assessment; Range 0-4 (better to worse).

  5. 30-day Mortality (Serum Lactate) [ Time Frame: 30 days ]
    Differences 30-day mortality between patients with high and with low Serum Lactate levels

  6. 30-day Mortality (Ferritin) [ Time Frame: 30 days ]
    Differences 30-day mortality between patients with high and with low Ferritin levels


Biospecimen Retention:   Samples With DNA
1 EDTA bood sample per blood culture set (2 per patient). 5mL of samples is used for validation of DNA-based diagnostics developed within the FAPIC-project. 4mL of samples is used for HLA-DR typing using flow cytometry. Left-overs are stored as plasma for future research.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with suspected sepsis, for whom blood cultures are drawn.
Criteria

Inclusion Criteria:

  • Patients for whom blood cultures are drawn
  • Age ≥ 18

Exclusion Criteria:

  • Age < 18
  • Patients who are not hospitalized and sent home after ED admission
  • Patients from the haematology department
  • Duplicate blood cultures from the same bacteraemia episode (blood cultures drawn <7 days after first blood culture)

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): NCT03841162


Locations
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Belgium
Jessa Hospital
Hasselt, Limburg, Belgium, 3500
Sponsors and Collaborators
Hasselt University
Jessa Hospital
University of Zagreb
Molzym
AIT Austrian Institute of Technology GmbH
BEE Robotics
University of Warwick
Claude Bernard University
Axo Science
Investigators
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Principal Investigator: Inge C Gyssens, MD, PhD Radboud University
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: prof. dr. Inge Gyssens, Principal Investigator, Radboud University
ClinicalTrials.gov Identifier: NCT03841162    
Other Study ID Numbers: 18.106/infect18.03
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
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 prof. dr. Inge Gyssens, Radboud University:
Blood Cultures
Additional relevant MeSH terms:
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Bacteremia
Sepsis
Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Bacterial Infections
Bacterial Infections and Mycoses