<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/NCT04410276</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-MS-15-0055</org_study_id>
    <nct_id>NCT04410276</nct_id>
  </id_info>
  <brief_title>VENOUS: A Translational Study of Enterococcal Bacteremia</brief_title>
  <official_title>VENOUS: A Translational Study of Enterococcal Bacteremia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Health Science Center, Houston</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>
      The purpose of this study is to assemble a multicenter prospective cohort of patients with&#xD;
      enterococcal bloodstream infections (BSIs) to provide data on outcomes of patients with&#xD;
      enterococcal BSIs for sample size calculations for future trials, as well as to characterize&#xD;
      enterococcal isolates causing BSIs in order to comprehensively dissect the molecular&#xD;
      epidemiology of infecting organisms for future studies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2016</start_date>
  <completion_date type="Anticipated">August 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2025</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>30 Days</target_duration>
  <primary_outcome>
    <measure>All-cause, in-hospital mortality</measure>
    <time_frame>30 days or until hospital discharge</time_frame>
    <description>Death by any cause while patient is in the hospital</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with microbiological outcome</measure>
    <time_frame>7 days after first documented positive blood culture</time_frame>
    <description>Eradication defined as a negative follow-up blood culture &gt; 4 days after index blood culture</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with recurrence of bacteremia</measure>
    <time_frame>14 days after the documented eradication of bacteremia</time_frame>
    <description>Positive blood culture with the same organism within the following 14 days after the documented eradication of bacteremia</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Enterococcal Bacteremia</condition>
  <arm_group>
    <arm_group_label>Patients with enterococcal bloodstream infections</arm_group_label>
    <description>Adult patients (≥ 18 years of age) with ≥ 1 positive blood cultures with Enterococcus during hospitalization and who have repeat blood culture(s) within 7 days from the first positive culture will be included.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Enterococcal isolates from index and subsequent blood cultures will be collected by the&#xD;
      research personnel from the clinical microbiology lab. Bacterial isolates will be processed&#xD;
      by conventional laboratory methods at each institution. Isolates will be stored at -80º&#xD;
      Celsius using local laboratory standards until shipment to central laboratory (UTHealth) for&#xD;
      storage and further characterization.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Hospitalized patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospitalized patient&#xD;
&#xD;
          -  ≥1 positive blood culture with Enterococcus spp. (VRE or VSE) during hospitalization&#xD;
&#xD;
          -  bacterial isolate(s) is/are available for further characterization&#xD;
&#xD;
          -  Repeat blood culture(s) within 7 days from the first positive culture&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cultures obtained from patients not admitted to the hospital&#xD;
&#xD;
          -  Isolate(s) not available for further studies.&#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>Cesar A. Arias, MD, MSc, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas Health Science Center, Houston</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cesar A. Arias, MD, MSc, PhD</last_name>
    <phone>(713) 500-9000</phone>
    <email>Cesar.Arias@uth.tmc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Truc T. Tran, PharmD</last_name>
    <phone>(713) 500-6748</phone>
    <email>Truc.T.Tran@uth.tmc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Jackson Health System, University of Miami Miller School of Medicine</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lilian Abbo, MD</last_name>
      <email>labbo@med.miami.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital and Medical Centers</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Katherine Reyes, MD, PhD</last_name>
      <email>Kreyes1@hfhs.org</email>
    </contact>
    <contact_backup>
      <last_name>Marcus Zeryos, MD</last_name>
      <email>mzervos@hfhs.org</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luis Shimose, MD</last_name>
      <email>lshimoseciudad@umc.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of North Carolina</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David van Duin, MD, PhD</last_name>
      <email>David_vanduin@med.unc.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh School of Medicine</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yohei Doi, MD, PhD</last_name>
      <email>yod4@pitt.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Samuel Shelburne, MD, PhD</last_name>
      <email>sshelburne@mdanderson.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cesar A. Arias, MD, MSc, PhD</last_name>
      <phone>713-500-9000</phone>
      <email>Cesar.Arias@uth.tmc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Truc T. Tran, PhD</last_name>
      <phone>(713) 500-6748</phone>
      <email>Truc.T.Tran@uth.tmc.edu</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Fred Hutchinson Cancer Research Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Catherine Liu, MD</last_name>
      <email>Catherine.liu@fredhutch.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Sanatorio</name>
      <address>
        <city>Buenos Aires</city>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fernanda Barberis, MD</last_name>
      <email>ferbarberis@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Padre Hurtado</name>
      <address>
        <city>Santiago</city>
        <country>Chile</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>José M. Munita, MD</last_name>
      <email>Jose.m.munita@uth.tmc.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Cologne</name>
      <address>
        <city>Cologne</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Harald Seifert, MD</last_name>
      <email>harald.seifert@uni-koeln.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari de Bellvitge</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carlota Guidiol, MD</last_name>
      <email>carlotasway@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Chile</country>
    <country>Germany</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>May 26, 2020</last_update_submitted>
  <last_update_submitted_qc>May 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
    <investigator_full_name>Cesar A Arias</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>entercoccal bloodstream infection</keyword>
  <keyword>vancomycin-resistant enterococci</keyword>
  <keyword>vancomycin-susceptible enterococci</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bacteremia</mesh_term>
  </condition_browse>
  <!-- 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/NCT04410276
org study id: HSC-MS-15-0055
nct id: NCT04410276
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assemble a multicenter prospective cohort of patients with
      enterococcal bloodstream infections (BSIs) to provide data on outcomes of patients with
      enterococcal BSIs for sample size calculations for future trials, as well as to characterize
      enterococcal isolates causing BSIs in order to comprehensively dissect the molecular
      epidemiology of infecting organisms for future studies.
observational model: Cohort
time perspective: Prospective
measure: All-cause, in-hospital mortality
time frame: 30 days or until hospital discharge
description: Death by any cause while patient is in the hospital
measure: Number of participants with microbiological outcome
time frame: 7 days after first documented positive blood culture
description: Eradication defined as a negative follow-up blood culture > 4 days after index blood culture
measure: Number of participants with recurrence of bacteremia
time frame: 14 days after the documented eradication of bacteremia
description: Positive blood culture with the same organism within the following 14 days after the documented eradication of bacteremia
arm group label: Patients with enterococcal bloodstream infections
description: Adult patients (≥ 18 years of age) with ≥ 1 positive blood cultures with Enterococcus during hospitalization and who have repeat blood culture(s) within 7 days from the first positive culture will be included.
Enterococcal isolates from index and subsequent blood cultures will be collected by the
      research personnel from the clinical microbiology lab. Bacterial isolates will be processed
      by conventional laboratory methods at each institution. Isolates will be stored at -80º
      Celsius using local laboratory standards until shipment to central laboratory (UTHealth) for
      storage and further characterization.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cesar A. Arias, MD, MSc, PhD
role: Principal Investigator
affiliation: The University of Texas Health Science Center, Houston
last name: Cesar A. Arias, MD, MSc, PhD
phone: (713) 500-9000
email: Cesar.Arias@uth.tmc.edu
last name: Truc T. Tran, PharmD
phone: (713) 500-6748
email: Truc.T.Tran@uth.tmc.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Argentina
country: Chile
country: Germany
country: Spain
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center, Houston
investigator full name: Cesar A Arias
investigator title: Professor
mesh term: Bacteremia