<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03841162</url>
  </required_header>
  <id_info>
    <org_study_id>18.106/infect18.03</org_study_id>
    <nct_id>NCT03841162</nct_id>
  </id_info>
  <brief_title>Fast Assay for Pathogen Identification and Characterization</brief_title>
  <acronym>FAPIC</acronym>
  <official_title>Fast Assay for Pathogen Identification and Characterization - Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hasselt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jessa Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Zagreb</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Molzym</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>AIT Austrian Institute of Technology GmbH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>BEE Robotics</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Warwick</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Claude Bernard University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Axo Science</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hasselt University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sepsis is a life-threatening disease caused by a dysregulated host response to infection.&#xD;
      This can lead to organ-dysfunction and septic shock, which is a subset of sepsis where&#xD;
      underlying abnormalities increase mortality remarkably. Blood cultures are the gold standard&#xD;
      for identifying pathogens in the bloodstream (bacteremia). It is based on cultivation&#xD;
      techniques which, theoretically, can detect a single pathogenic cell from a patient sample.&#xD;
      However, blood cultures have serious limitations, such as long time to result (3-7 days).&#xD;
      This leads to the fact that only a small fraction of the patients obtain a correct diagnosis&#xD;
      and in further consequence get the optimal antimicrobial treatment. Patients with sepsis&#xD;
      should get antimicrobial treatment within the hour. Thus, physicians start treatment&#xD;
      empirically, with broad-spectrum antibiotics. This puts a selective pressure on pathogens and&#xD;
      has led to an increased amount of antibiotic resistance. Faster diagnostics are necessary to&#xD;
      ensure an immediate and targeted treatment. In the EU-funded FAPIC project, two diagnostic&#xD;
      systems that can be used with direct sample material from patients will be developed,&#xD;
      avoiding the time-consuming cultivation of pathogens.&#xD;
&#xD;
      In this study, the evaluation of the rapid diagnostics will be performed in patients with&#xD;
      sepsis, suspected of bacteremia. To this aim, the performance of the diagnostic systems will&#xD;
      be evaluated using blood samples that are collected in parallel with blood cultures. In&#xD;
      addition, clinical data of the patients will be collected. In routine care, two blood culture&#xD;
      sets (2x2 bottles) per patient are collected. One extra blood samples (EDTA, 9 ml) will be&#xD;
      sampled with each blood culture set, totaling 2 samples per patient. In this study, patients&#xD;
      presenting at the Emergency Department (ED), and the department of infectious&#xD;
      diseases/nephrology will be included. The results will be used to estimate the performance,&#xD;
      sensitivity, and specificity of the diagnostic systems compared to blood culture.&#xD;
      Furthermore, in order to determine the severity of sepsis and to describe the patient&#xD;
      population, clinically relevant parameters and laboratory parameters (ferritin, HLA-DR, serum&#xD;
      lactate, SOFA score) will be assessed to determine its association with severity of disease&#xD;
      and patient mortality. Evaluation will be done exclusively in the lab, and will not be used&#xD;
      directly for the diagnosis or management of patients. Standard care will still be provided.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a follow-up study of the first prospective study performed in 2017 in the same&#xD;
      hospital. The ClinicalTrials.gov ID number of the previous study was NCT03025802.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 12, 2019</start_date>
  <completion_date type="Actual">April 17, 2020</completion_date>
  <primary_completion_date type="Actual">April 17, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Confirmed bacteremia based on positive blood cultures (SOFA score)</measure>
    <time_frame>7 days</time_frame>
    <description>Differences in SOFA score between patients with positive blood cultures and patients with negative blood cultures.&#xD;
SOFA: Sequential Organ Failure Assessment; Range 0-4 (better to worse).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Confirmed bacteremia based on positive blood cultures (Serum Lactate)</measure>
    <time_frame>7 days</time_frame>
    <description>Differences in Serum Lactate levels between patients with positive blood cultures and patients with negative blood cultures</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Confirmed bacteremia based on positive blood cultures (Ferritin)</measure>
    <time_frame>7 days</time_frame>
    <description>Differences in Ferritin levels between patients with positive blood cultures and patients with negative blood cultures</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Test performance</measure>
    <time_frame>1 year</time_frame>
    <description>Performance characteristics (Clinical sensitivity, specificity and accuracy) of a new rapid diagnostic systems</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of Stay (SOFA score)</measure>
    <time_frame>1 year</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Stay (Serum Lactate)</measure>
    <time_frame>1 year</time_frame>
    <description>Differences in length of stay between patients with high and with low Serum Lactate levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Stay (Ferritin)</measure>
    <time_frame>1 year</time_frame>
    <description>Differences in length of stay between patients with high and with low Ferritin levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-day Mortality (Sofa score)</measure>
    <time_frame>30 days</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-day Mortality (Serum Lactate)</measure>
    <time_frame>30 days</time_frame>
    <description>Differences 30-day mortality between patients with high and with low Serum Lactate levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-day Mortality (Ferritin)</measure>
    <time_frame>30 days</time_frame>
    <description>Differences 30-day mortality between patients with high and with low Ferritin levels</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1957</enrollment>
  <condition>Bacteremia</condition>
  <condition>Sepsis</condition>
  <condition>Septic Shock</condition>
  <arm_group>
    <arm_group_label>Patients with suspected sepsis</arm_group_label>
    <description>Patients for whom blood cultures are drawn at the Emergency Department or the department of Infectious Diseases/Nephrology</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      1 EDTA bood sample per blood culture set (2 per patient). 5mL of samples is used for&#xD;
      validation of DNA-based diagnostics developed within the FAPIC-project. 4mL of samples is&#xD;
      used for HLA-DR typing using flow cytometry. Left-overs are stored as plasma for future&#xD;
      research.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with suspected sepsis, for whom blood cultures are drawn.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients for whom blood cultures are drawn&#xD;
&#xD;
          -  Age ≥ 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18&#xD;
&#xD;
          -  Patients who are not hospitalized and sent home after ED admission&#xD;
&#xD;
          -  Patients from the haematology department&#xD;
&#xD;
          -  Duplicate blood cultures from the same bacteraemia episode (blood cultures drawn &lt;7&#xD;
             days after first blood culture)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Inge C Gyssens, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Radboud University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jessa Hospital</name>
      <address>
        <city>Hasselt</city>
        <state>Limburg</state>
        <zip>3500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <link>
    <url>http://www.fapic.eu</url>
    <description>FAPIC project website</description>
  </link>
  <reference>
    <citation>Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.</citation>
    <PMID>26903338</PMID>
  </reference>
  <reference>
    <citation>Shankar-Hari M, Phillips GS, Levy ML, Seymour CW, Liu VX, Deutschman CS, Angus DC, Rubenfeld GD, Singer M; Sepsis Definitions Task Force. Developing a New Definition and Assessing New Clinical Criteria for Septic Shock: For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):775-87. doi: 10.1001/jama.2016.0289.</citation>
    <PMID>26903336</PMID>
  </reference>
  <reference>
    <citation>Faix JD. Biomarkers of sepsis. Crit Rev Clin Lab Sci. 2013 Jan-Feb;50(1):23-36. doi: 10.3109/10408363.2013.764490.</citation>
    <PMID>23480440</PMID>
  </reference>
  <reference>
    <citation>Lvovschi V, Arnaud L, Parizot C, Freund Y, Juillien G, Ghillani-Dalbin P, Bouberima M, Larsen M, Riou B, Gorochov G, Hausfater P. Cytokine profiles in sepsis have limited relevance for stratifying patients in the emergency department: a prospective observational study. PLoS One. 2011;6(12):e28870. doi: 10.1371/journal.pone.0028870. Epub 2011 Dec 29. Erratum In: PLoS One. 2012;7(1). doi: 10.1371/annotation/bc7e1a29-020d-4320-8f07-4dda4147fe11.</citation>
    <PMID>22220196</PMID>
  </reference>
  <reference>
    <citation>Kibe S, Adams K, Barlow G. Diagnostic and prognostic biomarkers of sepsis in critical care. J Antimicrob Chemother. 2011 Apr;66 Suppl 2:ii33-40. doi: 10.1093/jac/dkq523.</citation>
    <PMID>21398306</PMID>
  </reference>
  <reference>
    <citation>Cinel I, Opal SM. Molecular biology of inflammation and sepsis: a primer. Crit Care Med. 2009 Jan;37(1):291-304. doi: 10.1097/CCM.0b013e31819267fb.</citation>
    <PMID>19050640</PMID>
  </reference>
  <reference>
    <citation>Gogos CA, Drosou E, Bassaris HP, Skoutelis A. Pro- versus anti-inflammatory cytokine profile in patients with severe sepsis: a marker for prognosis and future therapeutic options. J Infect Dis. 2000 Jan;181(1):176-80. doi: 10.1086/315214.</citation>
    <PMID>10608764</PMID>
  </reference>
  <reference>
    <citation>Rosario C, Zandman-Goddard G, Meyron-Holtz EG, D'Cruz DP, Shoenfeld Y. The hyperferritinemic syndrome: macrophage activation syndrome, Still's disease, septic shock and catastrophic antiphospholipid syndrome. BMC Med. 2013 Aug 22;11:185. doi: 10.1186/1741-7015-11-185.</citation>
    <PMID>23968282</PMID>
  </reference>
  <reference>
    <citation>Schulert GS, Grom AA. Pathogenesis of macrophage activation syndrome and potential for cytokine- directed therapies. Annu Rev Med. 2015;66:145-59. doi: 10.1146/annurev-med-061813-012806. Epub 2014 Nov 5.</citation>
    <PMID>25386930</PMID>
  </reference>
  <reference>
    <citation>Kell DB, Pretorius E. Serum ferritin is an important inflammatory disease marker, as it is mainly a leakage product from damaged cells. Metallomics. 2014 Apr;6(4):748-73. doi: 10.1039/c3mt00347g.</citation>
    <PMID>24549403</PMID>
  </reference>
  <reference>
    <citation>Carcillo JA, Simon DW, Podd BS. How We Manage Hyperferritinemic Sepsis-Related Multiple Organ Dysfunction Syndrome/Macrophage Activation Syndrome/Secondary Hemophagocytic Lymphohistiocytosis Histiocytosis. Pediatr Crit Care Med. 2015 Jul;16(6):598-600. doi: 10.1097/PCC.0000000000000460. No abstract available.</citation>
    <PMID>26154908</PMID>
  </reference>
  <reference>
    <citation>Bennett TD, Hayward KN, Farris RW, Ringold S, Wallace CA, Brogan TV. Very high serum ferritin levels are associated with increased mortality and critical care in pediatric patients. Pediatr Crit Care Med. 2011 Nov;12(6):e233-6. doi: 10.1097/PCC.0b013e31820abca8.</citation>
    <PMID>21263363</PMID>
  </reference>
  <reference>
    <citation>Kyriazopoulou E, Leventogiannis K, Norrby-Teglund A, Dimopoulos G, Pantazi A, Orfanos SE, Rovina N, Tsangaris I, Gkavogianni T, Botsa E, Chassiou E, Kotanidou A, Kontouli C, Chaloulis P, Velissaris D, Savva A, Cullberg JS, Akinosoglou K, Gogos C, Armaganidis A, Giamarellos-Bourboulis EJ; Hellenic Sepsis Study Group. Macrophage activation-like syndrome: an immunological entity associated with rapid progression to death in sepsis. BMC Med. 2017 Sep 18;15(1):172. doi: 10.1186/s12916-017-0930-5.</citation>
    <PMID>28918754</PMID>
  </reference>
  <reference>
    <citation>Shakoory B, Carcillo JA, Chatham WW, Amdur RL, Zhao H, Dinarello CA, Cron RQ, Opal SM. Interleukin-1 Receptor Blockade Is Associated With Reduced Mortality in Sepsis Patients With Features of Macrophage Activation Syndrome: Reanalysis of a Prior Phase III Trial. Crit Care Med. 2016 Feb;44(2):275-81. doi: 10.1097/CCM.0000000000001402.</citation>
    <PMID>26584195</PMID>
  </reference>
  <reference>
    <citation>Antonakos N, Tsaganos T, Oberle V, Tsangaris I, Lada M, Pistiki A, Machairas N, Souli M, Bauer M, Giamarellos-Bourboulis EJ. Decreased cytokine production by mononuclear cells after severe gram-negative infections: early clinical signs and association with final outcome. Crit Care. 2017 Mar 9;21(1):48. doi: 10.1186/s13054-017-1625-1.</citation>
    <PMID>28274246</PMID>
  </reference>
  <reference>
    <citation>Gainaru G, Papadopoulos A, Tsangaris I, Lada M, Giamarellos-Bourboulis EJ, Pistiki A. Increases in inflammatory and CD14dim/CD16pos/CD45pos patrolling monocytes in sepsis: correlation with final outcome. Crit Care. 2018 Mar 3;22(1):56. doi: 10.1186/s13054-018-1977-1.</citation>
    <PMID>29499723</PMID>
  </reference>
  <reference>
    <citation>Drewry AM, Ablordeppey EA, Murray ET, Beiter ER, Walton AH, Hall MW, Hotchkiss RS. Comparison of monocyte human leukocyte antigen-DR expression and stimulated tumor necrosis factor alpha production as outcome predictors in severe sepsis: a prospective observational study. Crit Care. 2016 Oct 20;20(1):334. doi: 10.1186/s13054-016-1505-0.</citation>
    <PMID>27760554</PMID>
  </reference>
  <reference>
    <citation>Cazalis MA, Friggeri A, Cave L, Demaret J, Barbalat V, Cerrato E, Lepape A, Pachot A, Monneret G, Venet F. Decreased HLA-DR antigen-associated invariant chain (CD74) mRNA expression predicts mortality after septic shock. Crit Care. 2013 Dec 10;17(6):R287. doi: 10.1186/cc13150.</citation>
    <PMID>24321376</PMID>
  </reference>
  <reference>
    <citation>Wang AY, Ma HP, Kao WF, Tsai SH, Chang CK. Red blood cell distribution width is associated with mortality in elderly patients with sepsis. Am J Emerg Med. 2018 Jun;36(6):949-953. doi: 10.1016/j.ajem.2017.10.056. Epub 2017 Nov 10.</citation>
    <PMID>29133071</PMID>
  </reference>
  <reference>
    <citation>Kim CH, Park JT, Kim EJ, Han JH, Han JS, Choi JY, Han SH, Yoo TH, Kim YS, Kang SW, Oh HJ. An increase in red blood cell distribution width from baseline predicts mortality in patients with severe sepsis or septic shock. Crit Care. 2013 Dec 9;17(6):R282. doi: 10.1186/cc13145.</citation>
    <PMID>24321201</PMID>
  </reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>April 28, 2020</last_update_submitted>
  <last_update_submitted_qc>April 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Radboud University Medical Center</investigator_affiliation>
    <investigator_full_name>prof. dr. Inge Gyssens</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Blood Cultures</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bacteremia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03841162
org study id: 18.106/infect18.03
nct id: NCT03841162
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Confirmed bacteremia based on positive blood cultures (SOFA score)
time frame: 7 days
description: 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).
measure: Confirmed bacteremia based on positive blood cultures (Serum Lactate)
time frame: 7 days
description: Differences in Serum Lactate levels between patients with positive blood cultures and patients with negative blood cultures
measure: Confirmed bacteremia based on positive blood cultures (Ferritin)
time frame: 7 days
description: Differences in Ferritin levels between patients with positive blood cultures and patients with negative blood cultures
measure: Test performance
time frame: 1 year
description: Performance characteristics (Clinical sensitivity, specificity and accuracy) of a new rapid diagnostic systems
measure: Length of Stay (SOFA score)
time frame: 1 year
description: 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).
measure: Length of Stay (Serum Lactate)
time frame: 1 year
description: Differences in length of stay between patients with high and with low Serum Lactate levels
measure: Length of Stay (Ferritin)
time frame: 1 year
description: Differences in length of stay between patients with high and with low Ferritin levels
measure: 30-day Mortality (Sofa score)
time frame: 30 days
description: 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).
measure: 30-day Mortality (Serum Lactate)
time frame: 30 days
description: Differences 30-day mortality between patients with high and with low Serum Lactate levels
measure: 30-day Mortality (Ferritin)
time frame: 30 days
description: Differences 30-day mortality between patients with high and with low Ferritin levels
arm group label: Patients with suspected sepsis
description: Patients for whom blood cultures are drawn at the Emergency Department or the department of Infectious Diseases/Nephrology
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.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Inge C Gyssens, MD, PhD
role: Principal Investigator
affiliation: Radboud University Medical Center
facility: 
country: Belgium
url: http://www.fapic.eu
description: FAPIC project website
citation: Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
PMID: 26903338
citation: Shankar-Hari M, Phillips GS, Levy ML, Seymour CW, Liu VX, Deutschman CS, Angus DC, Rubenfeld GD, Singer M; Sepsis Definitions Task Force. Developing a New Definition and Assessing New Clinical Criteria for Septic Shock: For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):775-87. doi: 10.1001/jama.2016.0289.
PMID: 26903336
citation: Faix JD. Biomarkers of sepsis. Crit Rev Clin Lab Sci. 2013 Jan-Feb;50(1):23-36. doi: 10.3109/10408363.2013.764490.
PMID: 23480440
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responsible party type: Principal Investigator
investigator affiliation: Radboud University Medical Center
investigator full name: prof. dr. Inge Gyssens
investigator title: Principal Investigator
mesh term: Bacteremia
sharing ipd: No