<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/NCT01688258</url>
  </required_header>
  <id_info>
    <org_study_id>GUD-PCR</org_study_id>
    <nct_id>NCT01688258</nct_id>
  </id_info>
  <brief_title>New Multiplex Real-time PCR for Genital Ulcer Disease</brief_title>
  <official_title>A Prospective, Open Labeled, Multicenter, Diagnostic Study on the Detection of T. Pallidum, H. Ducreyi and HSV Type 1 and 2 From Genital, Anal and Oropharyngeal Ulcers With a New Multiplex Real-time Polymerase Chain Reaction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</source>
  <brief_summary>
    <textblock>
      (i) To compare a new diagnostic PCR with established diagnostic procedures for T. pallidum&#xD;
      (serology, dark field microscopy), H. ducreyi (cultivation), HSV types 1 and 2 (cultivation,&#xD;
      PCR).&#xD;
&#xD;
      (ii) To assess the frequency of infections with T. pallidum, H. ducreyi and HSV types 1 and 2&#xD;
      in patients with genital, anal and oropharyngeal ulcers by a new PCR.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <enrollment type="Actual">50</enrollment>
  <condition>Genital Ulcer Disease (GUD)</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Diagnostic swab</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with genital, anal or oropharyngeal ulcers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Patient with genital, anal or oropharyngeal ulcers&#xD;
&#xD;
          -  Age minimum of 18 years.&#xD;
&#xD;
          -  Informed consent must be obtained from each patient/control patient in written form&#xD;
             prior to any study procedure.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Antibiotic therapy within 2 weeks before the visit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philipp Bosshard, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Zurich, Division of Dermatology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Zurich, Division of Dermatology</name>
      <address>
        <city>Zurich</city>
        <state>ZH</state>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>July 12, 2017</last_update_submitted>
  <last_update_submitted_qc>July 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ulcer</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/NCT01688258
org study id: GUD-PCR
nct id: NCT01688258
lead sponsor: 
(i) To compare a new diagnostic PCR with established diagnostic procedures for T. pallidum
      (serology, dark field microscopy), H. ducreyi (cultivation), HSV types 1 and 2 (cultivation,
      PCR).

      (ii) To assess the frequency of infections with T. pallidum, H. ducreyi and HSV types 1 and 2
      in patients with genital, anal and oropharyngeal ulcers by a new PCR.
observational model: Other
time perspective: Prospective
intervention type: Procedure
intervention name: Diagnostic swab
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Philipp Bosshard, PhD
role: Principal Investigator
affiliation: University Hospital Zurich, Division of Dermatology
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Ulcer