<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/NCT03025802</url>
  </required_header>
  <id_info>
    <org_study_id>16.120/infect16.04</org_study_id>
    <nct_id>NCT03025802</nct_id>
  </id_info>
  <brief_title>Fast Assay for Pathogen Identification and Characterization - Prospective Study</brief_title>
  <acronym>FAPIC</acronym>
  <official_title>Fast Assay for Pathogen Identification and Characterization - Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hasselt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AIT Austrian Institute of Technology GmbH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Zagreb</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jessa Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hasselt University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The FAPIC project will develop a diagnostic system that will identify pathogens and&#xD;
      charachterize virulence and resistance. A prospective study will be performed in which blood&#xD;
      samples will be collected of patients with suspected sepsis in order to evaluate the&#xD;
      diagnostic system. In routine care, blood is drawn of these patients for culture in order to&#xD;
      identify the causative pathogen. This process takes 3-5 days. During the study, one extra&#xD;
      blood sample will be collected with the same venipuncture, with each blood culture.&#xD;
      Afterwards, routine diagnosis by blood culture is followed. Blood samples will be send to the&#xD;
      research laboratories for determination of sensitivity and specificity. The system will not&#xD;
      be used in the clinic.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Detection of pathogens and its virulence factors and susceptibility genes</measure>
    <time_frame>1 year</time_frame>
    <description>Sensitivity, specificity, and accuracy of the molecular system compared to blood culture.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Population outcome during routine procedures</measure>
    <time_frame>1 year</time_frame>
    <description>Insights on routine hospital procedures using blood culture and outcomes on the study population such as TAT, antimicrobial use, time to antimicrobial change, in-hospital stay, and mortality by collection of patient data in the medical records.</description>
  </secondary_outcome>
  <enrollment type="Actual">238</enrollment>
  <condition>Sepsis</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        A prospective cohort will be set up to determine and evaluate the performance of the&#xD;
        diagnostic system. The cohort will consist of 250 patients (~500 blood culture sets) with&#xD;
        suspicion of bacteremia, for whom routine blood cultures are ordered.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Older than 18 years&#xD;
&#xD;
          -  Suspicion of bacteremia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children (&lt;18 years)&#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>Hasselt University</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>
    <facility>
      <name>University of Zagreb Medical School</name>
      <address>
        <city>Zagreb</city>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Croatia</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>Martin GS. Sepsis, severe sepsis and septic shock: changes in incidence, pathogens and outcomes. Expert Rev Anti Infect Ther. 2012 Jun;10(6):701-6. doi: 10.1586/eri.12.50.</citation>
    <PMID>22734959</PMID>
  </reference>
  <reference>
    <citation>Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb S, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including The Pediatric Subgroup. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock, 2012. Intensive Care Med. 2013 Feb;39(2):165-228. doi: 10.1007/s00134-012-2769-8. Epub 2013 Jan 30.</citation>
    <PMID>23361625</PMID>
  </reference>
  <reference>
    <citation>Yoshikawa TT. Antimicrobial resistance and aging: beginning of the end of the antibiotic era? J Am Geriatr Soc. 2002 Jul;50(7 Suppl):S226-9. doi: 10.1046/j.1532-5415.50.7s.2.x.</citation>
    <PMID>12121517</PMID>
  </reference>
  <reference>
    <citation>Corona A, Colombo R. Towards the end of the antibiotic era: let's save the ancient soldier Colistin! Intensive Care Med. 2013 Sep;39(9):1660-1. doi: 10.1007/s00134-013-2955-3. Epub 2013 May 22. No abstract available.</citation>
    <PMID>23695267</PMID>
  </reference>
  <reference>
    <citation>Hede K. Antibiotic resistance: An infectious arms race. Nature. 2014 May 1;509(7498):S2-3. doi: 10.1038/509S2a. No abstract available.</citation>
    <PMID>24784426</PMID>
  </reference>
  <reference>
    <citation>Bush K. Alarming beta-lactamase-mediated resistance in multidrug-resistant Enterobacteriaceae. Curr Opin Microbiol. 2010 Oct;13(5):558-64. doi: 10.1016/j.mib.2010.09.006. Epub 2010 Oct 1.</citation>
    <PMID>20920882</PMID>
  </reference>
  <reference>
    <citation>Zankari E, Hasman H, Cosentino S, Vestergaard M, Rasmussen S, Lund O, Aarestrup FM, Larsen MV. Identification of acquired antimicrobial resistance genes. J Antimicrob Chemother. 2012 Nov;67(11):2640-4. doi: 10.1093/jac/dks261. Epub 2012 Jul 10.</citation>
    <PMID>22782487</PMID>
  </reference>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>May 19, 2018</last_update_submitted>
  <last_update_submitted_qc>May 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hasselt University</investigator_affiliation>
    <investigator_full_name>prof. dr. Inge Gyssens</investigator_full_name>
    <investigator_title>Prof. dr.</investigator_title>
  </responsible_party>
  <keyword>Molecular diagnosis</keyword>
  <keyword>Pathogen identification</keyword>
  <keyword>Sepsis</keyword>
  <keyword>Bacteremia</keyword>
  <keyword>Rapid diagnostics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sepsis</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/NCT03025802
org study id: 16.120/infect16.04
nct id: NCT03025802
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The FAPIC project will develop a diagnostic system that will identify pathogens and
      charachterize virulence and resistance. A prospective study will be performed in which blood
      samples will be collected of patients with suspected sepsis in order to evaluate the
      diagnostic system. In routine care, blood is drawn of these patients for culture in order to
      identify the causative pathogen. This process takes 3-5 days. During the study, one extra
      blood sample will be collected with the same venipuncture, with each blood culture.
      Afterwards, routine diagnosis by blood culture is followed. Blood samples will be send to the
      research laboratories for determination of sensitivity and specificity. The system will not
      be used in the clinic.
observational model: Cohort
time perspective: Prospective
measure: Detection of pathogens and its virulence factors and susceptibility genes
time frame: 1 year
description: Sensitivity, specificity, and accuracy of the molecular system compared to blood culture.
measure: Population outcome during routine procedures
time frame: 1 year
description: Insights on routine hospital procedures using blood culture and outcomes on the study population such as TAT, antimicrobial use, time to antimicrobial change, in-hospital stay, and mortality by collection of patient data in the medical records.
Whole blood
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: Hasselt University
facility: 
facility: 
country: Belgium
country: Croatia
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: Martin GS. Sepsis, severe sepsis and septic shock: changes in incidence, pathogens and outcomes. Expert Rev Anti Infect Ther. 2012 Jun;10(6):701-6. doi: 10.1586/eri.12.50.
PMID: 22734959
citation: Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb S, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including The Pediatric Subgroup. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock, 2012. Intensive Care Med. 2013 Feb;39(2):165-228. doi: 10.1007/s00134-012-2769-8. Epub 2013 Jan 30.
PMID: 23361625
citation: Yoshikawa TT. Antimicrobial resistance and aging: beginning of the end of the antibiotic era? J Am Geriatr Soc. 2002 Jul;50(7 Suppl):S226-9. doi: 10.1046/j.1532-5415.50.7s.2.x.
PMID: 12121517
citation: Corona A, Colombo R. Towards the end of the antibiotic era: let's save the ancient soldier Colistin! Intensive Care Med. 2013 Sep;39(9):1660-1. doi: 10.1007/s00134-013-2955-3. Epub 2013 May 22. No abstract available.
PMID: 23695267
citation: Hede K. Antibiotic resistance: An infectious arms race. Nature. 2014 May 1;509(7498):S2-3. doi: 10.1038/509S2a. No abstract available.
PMID: 24784426
citation: Bush K. Alarming beta-lactamase-mediated resistance in multidrug-resistant Enterobacteriaceae. Curr Opin Microbiol. 2010 Oct;13(5):558-64. doi: 10.1016/j.mib.2010.09.006. Epub 2010 Oct 1.
PMID: 20920882
citation: Zankari E, Hasman H, Cosentino S, Vestergaard M, Rasmussen S, Lund O, Aarestrup FM, Larsen MV. Identification of acquired antimicrobial resistance genes. J Antimicrob Chemother. 2012 Nov;67(11):2640-4. doi: 10.1093/jac/dks261. Epub 2012 Jul 10.
PMID: 22782487
responsible party type: Principal Investigator
investigator affiliation: Hasselt University
investigator full name: prof. dr. Inge Gyssens
investigator title: Prof. dr.
mesh term: Sepsis
sharing ipd: No