<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/NCT03229421</url>
  </required_header>
  <id_info>
    <org_study_id>STU00205325</org_study_id>
    <nct_id>NCT03229421</nct_id>
  </id_info>
  <brief_title>Dermatologic Manifestations of Zika Virus</brief_title>
  <acronym>DMZV</acronym>
  <official_title>Survey of Symptoms and Dermatologic Characterization Associated With Zika Virus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pontificia Universidad Catolica Madre y Maestra</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwestern 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>
      The purpose of this study is to determine whether any diagnostic patterns exist in the&#xD;
      symptom presentation of Zika Virus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study has both retrospective and prospective components. The retrospective review&#xD;
      includes medical records with laboratory confirmed Zika Virus diagnosis and the prospective&#xD;
      component will enroll adults presenting with febrile illness and rash and ask them to&#xD;
      complete a survey about their symptoms. Diagnostic testing will be completed to confirm&#xD;
      infection source.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Unable to enroll eligible participants&#xD;
  </why_stopped>
  <start_date type="Actual">July 6, 2017</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of days with specific symptoms</measure>
    <time_frame>20 minutes</time_frame>
    <description>Number of days reported experiencing specific symptoms due to Zika Virus infection and and associated characteristics such as location and intensity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency measures of initial clinical presentations</measure>
    <time_frame>20 minutes</time_frame>
    <description>Frequency of reported symptoms at initial clinical presentation.</description>
  </secondary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Zika Virus Symptoms and the Associated Exanthema</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey</intervention_name>
    <description>18 question symptom assessment tool including non-identifying demographic information questions.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults 18 y/o with confirmed zika virus diagnosis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged 18 years and older presenting with febrile illness and rash&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients aged 17 years or younger&#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>Roopal V. Kundu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pontificia Universidad Catolica Madre y Maestra, Departamento de Medicina</name>
      <address>
        <city>Santo Domingo</city>
        <state>Illinois</state>
        <country>Dominican Republic</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Dominican Republic</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>July 18, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>January 31, 2019</last_update_submitted>
  <last_update_submitted_qc>January 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Roopal Kundu</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Zika Virus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Zika Virus Infection</mesh_term>
    <mesh_term>Exanthema</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/NCT03229421
org study id: STU00205325
nct id: NCT03229421
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine whether any diagnostic patterns exist in the
      symptom presentation of Zika Virus.
The study has both retrospective and prospective components. The retrospective review
      includes medical records with laboratory confirmed Zika Virus diagnosis and the prospective
      component will enroll adults presenting with febrile illness and rash and ask them to
      complete a survey about their symptoms. Diagnostic testing will be completed to confirm
      infection source.
observational model: Case-Only
time perspective: Prospective
measure: Number of days with specific symptoms
time frame: 20 minutes
description: Number of days reported experiencing specific symptoms due to Zika Virus infection and and associated characteristics such as location and intensity
measure: Frequency measures of initial clinical presentations
time frame: 20 minutes
description: Frequency of reported symptoms at initial clinical presentation.
intervention type: Other
intervention name: Survey
description: 18 question symptom assessment tool including non-identifying demographic information questions.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roopal V. Kundu, MD
role: Principal Investigator
affiliation: Northwestern University
facility: 
country: Dominican Republic
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Roopal Kundu
investigator title: Principal Investigator
mesh term: Zika Virus Infection
mesh term: Exanthema
sharing ipd: No