<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/NCT03827330</url>
  </required_header>
  <id_info>
    <org_study_id>999919037</org_study_id>
    <secondary_id>19-I-N037</secondary_id>
    <nct_id>NCT03827330</nct_id>
  </id_info>
  <brief_title>Retrospective Chart Review of Candida Fungemia</brief_title>
  <official_title>Retrospective Chart Review of Candida Fungemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      Candida can cause infections. The most common kind of Candida at clinics is C albicans. But&#xD;
      other kinds have increased at clinics too. Researchers want to review the records of people&#xD;
      who were in previous NIH studies who had Candida. They want to find out what risk factors are&#xD;
      associaated with this infection.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To study the factors that are associated with Candida fungemia to develop. The factors are&#xD;
      clinical features, diagnoses, and previous antifungal therapy.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      People who were in prior NIH studies and had Candida&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Researchers will review the records of 62 NIH participants. The records are from 2004 to&#xD;
      2017. They will look at data such as blood test results, diagnosis, and treatments.&#xD;
&#xD;
      Researchers will only reach out to participants if they get approval from a review board.&#xD;
&#xD;
      This research will probably not reveal data that would be important to participants health.&#xD;
      But if it does, researchers will try to contact those participants.&#xD;
&#xD;
      Data will be stored in secure computers. They will be stored with a code that only the study&#xD;
      team can link to a participant.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This protocol is a chart review of patients who had Candida species grown from blood cultures&#xD;
      drawn at the National Institutes of Health. The study will involve only review of patient&#xD;
      records and will not require new specimens or participant contact. The patients whose records&#xD;
      will be reviewed in this protocol are/were enrolled on a number of different protocols&#xD;
      related to their underlying disease(s). Principal investigators of each protocol have been&#xD;
      contacted to request permission to conduct this study, and to verify that none of the&#xD;
      original protocols or informed consent documents precludes such a review of clinical data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 3, 2019</start_date>
  <completion_date type="Actual">November 18, 2020</completion_date>
  <primary_completion_date type="Actual">November 18, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The objective of this protocol is to characterize the clinical features, underlying diagnoses, previous antimicrobial therapy, and previous antifungal therapy associated with the development of Candida fungemia, as well as the enrichment of n...</measure>
    <time_frame>Duration of study</time_frame>
    <description>The objective of this protocol is to characterize the clinical features, underlying diagnoses, previous antimicrobial therapy, and previous antifungal therapy associated with the development of Candida fungemia, as well as the enrichment of non-albicans species of Candida.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">75</enrollment>
  <condition>Candida Fungemia</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <description>Patients who had Candida species growth from blood cultures drawn at the National Institutes of Health</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who had Candida species grown from blood cultures drawn at the National Institutes&#xD;
        of Health from 2004 until 2017.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  The study will involve only review of patient records and will not require new&#xD;
             specimens or participant contact. The patients whose records will be reviewed in this&#xD;
             protocol are/were enrolled on a number of different protocols related to their&#xD;
             underlying disease(s).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michail S Lionakis, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institute of Allergy and Infectious Diseases (NIAID)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institute of Allergy and Infectious Diseases (NIAID)</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>November 24, 2020</last_update_submitted>
  <last_update_submitted_qc>November 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Candida Parapsilosis</keyword>
  <keyword>Candida Auris</keyword>
  <keyword>Candida Lusitaniae</keyword>
  <keyword>Candida Glabrata</keyword>
  <keyword>Candida Albicans</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fungemia</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/NCT03827330
org study id: 999919037
secondary id: 19-I-N037
nct id: NCT03827330
lead sponsor: 
Background:

      Candida can cause infections. The most common kind of Candida at clinics is C albicans. But
      other kinds have increased at clinics too. Researchers want to review the records of people
      who were in previous NIH studies who had Candida. They want to find out what risk factors are
      associaated with this infection.

      Objective:

      To study the factors that are associated with Candida fungemia to develop. The factors are
      clinical features, diagnoses, and previous antifungal therapy.

      Eligibility:

      People who were in prior NIH studies and had Candida

      Design:

      Researchers will review the records of 62 NIH participants. The records are from 2004 to
      2017. They will look at data such as blood test results, diagnosis, and treatments.

      Researchers will only reach out to participants if they get approval from a review board.

      This research will probably not reveal data that would be important to participants health.
      But if it does, researchers will try to contact those participants.

      Data will be stored in secure computers. They will be stored with a code that only the study
      team can link to a participant.
This protocol is a chart review of patients who had Candida species grown from blood cultures
      drawn at the National Institutes of Health. The study will involve only review of patient
      records and will not require new specimens or participant contact. The patients whose records
      will be reviewed in this protocol are/were enrolled on a number of different protocols
      related to their underlying disease(s). Principal investigators of each protocol have been
      contacted to request permission to conduct this study, and to verify that none of the
      original protocols or informed consent documents precludes such a review of clinical data.
observational model: Cohort
time perspective: Retrospective
measure: The objective of this protocol is to characterize the clinical features, underlying diagnoses, previous antimicrobial therapy, and previous antifungal therapy associated with the development of Candida fungemia, as well as the enrichment of n...
time frame: Duration of study
description: The objective of this protocol is to characterize the clinical features, underlying diagnoses, previous antimicrobial therapy, and previous antifungal therapy associated with the development of Candida fungemia, as well as the enrichment of non-albicans species of Candida.
arm group label: Patients
description: Patients who had Candida species growth from blood cultures drawn at the National Institutes of Health
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: N/A
healthy volunteers: No
last name: Michail S Lionakis, M.D.
role: Principal Investigator
affiliation: National Institute of Allergy and Infectious Diseases (NIAID)
facility: 
country: United States
responsible party type: Sponsor
mesh term: Fungemia