New Multiplex Real-time PCR for Genital Ulcer Disease

July 12, 2017 updated by: University of Zurich

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

(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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, 8091
        • University Hospital Zurich, Division of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with genital, anal or oropharyngeal ulcers

Description

Inclusion criteria:

  • Patient with genital, anal or oropharyngeal ulcers
  • Age minimum of 18 years.
  • Informed consent must be obtained from each patient/control patient in written form prior to any study procedure.

Exclusion criteria:

  • Antibiotic therapy within 2 weeks before the visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Philipp Bosshard, PhD, University Hospital Zurich, Division of Dermatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

September 14, 2012

First Submitted That Met QC Criteria

September 18, 2012

First Posted (Estimate)

September 19, 2012

Study Record Updates

Last Update Posted (Actual)

July 13, 2017

Last Update Submitted That Met QC Criteria

July 12, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GUD-PCR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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