<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/NCT04502355</url>
  </required_header>
  <id_info>
    <org_study_id>0483-16-RMC</org_study_id>
    <nct_id>NCT04502355</nct_id>
  </id_info>
  <brief_title>Voriconazole-Induced QT Interval Prolongation: A Prospective Study</brief_title>
  <official_title>Voriconazole-Induced QT Interval Prolongation: A Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rabin Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rabin Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The antifungal voriconazole is effective for the treatment of invasive fungal infections in&#xD;
      immunocompromised patients. A serious adverse reaction is QT interval prolongation, which may&#xD;
      precede life-threatening arrhythmias, such as torsades de pointes. Although ventricular&#xD;
      arrhythmias are mentioned as a possible adverse effect of voriconazole, thus far, the&#xD;
      incidence and clear recommendations for QT follow-up have not been published. This&#xD;
      prospective observational study aimed at describing the incidence of voriconazole induced- QT&#xD;
      interval prolongation in the pediatric population and determine the risk factors for this&#xD;
      phenomenon.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 31, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>QT interval prolongation</measure>
    <time_frame>up to three months of treatment</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Voriconazole Induced QT Interval Prolongation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Children aged 0-20 years treated with oral or IV voriconazole at the Schneider Children's&#xD;
        Medical Center from Oct 31st 2016.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  oral or IV treatment with voriconazole&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No data prior to initiation of voriconazole treatment on QT interval (baseline ECG)&#xD;
&#xD;
          -  Renal insufficiency or dialysis treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>20 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Schneider childrens medical center of Isreal</name>
      <address>
        <city>Petah Tikva</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Odelia Matz</last_name>
      <phone>+972-54-4634718</phone>
      <email>odeliama1@clalit.org.il</email>
    </contact>
    <contact_backup>
      <last_name>Liat Ashkenazi-Hoffnung, MD</last_name>
      <phone>+972-54-4749345</phone>
      <email>liata3@clalit.org.il</email>
    </contact_backup>
    <investigator>
      <last_name>Liat Ashkenazy-Hoffnung, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Itzhak Levy, MD, MPH</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Havatzelet Yarden-Bilavsky, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>voriconazole, ECG, arrhythmia</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04502355
org study id: 0483-16-RMC
nct id: NCT04502355
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The antifungal voriconazole is effective for the treatment of invasive fungal infections in
      immunocompromised patients. A serious adverse reaction is QT interval prolongation, which may
      precede life-threatening arrhythmias, such as torsades de pointes. Although ventricular
      arrhythmias are mentioned as a possible adverse effect of voriconazole, thus far, the
      incidence and clear recommendations for QT follow-up have not been published. This
      prospective observational study aimed at describing the incidence of voriconazole induced- QT
      interval prolongation in the pediatric population and determine the risk factors for this
      phenomenon.
observational model: Cohort
time perspective: Prospective
measure: QT interval prolongation
time frame: up to three months of treatment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 20 Years
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: Israel
responsible party type: Sponsor
sharing ipd: Undecided