New Multiplex Real-time PCR for Genital Ulcer Disease

Genital Ulcer Disease (GUD) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01688258
• Other study ID #: GUD-PCR
• Status: Completed
• Phase: N/A
• First received: September 14, 2012
• Last updated: July 12, 2017
• Start date: January 2012
• Est. completion date: July 2013

Study information

• Verified date: July 2017
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

(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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Genital Ulcer Disease (GUD)
• Ulcer

Intervention

Procedure:
• Diagnostic swab

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Division of Dermatology	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland,