Genital Ulcer Disease (GUD)NCT01688258
New Multiplex Real-time PCR for Genital Ulcer Disease
An observational study of Genital Ulcer Disease (GUD), run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Genital Ulcer Disease (GUD)
- What is being tested?
- Diagnostic swab
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2012to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with genital, anal or oropharyngeal ulcers
Who may be able to join
- 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.
Who cannot join
- Antibiotic therapy within 2 weeks before the visit
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Dermatology
Zurich, Canton of Zurich, 8091
About this study
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
(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.
- Conditions
- Genital Ulcer Disease (GUD)
- Being tested
- Diagnostic swab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic swabProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startJan 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Genital Ulcer Disease (GUD)Studies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philipp Bosshard, PhD, Principal investigator, University Hospital Zurich, Division of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688258
- Sponsor's protocol ID
- GUD-PCR
- Status last verified
- Jul 2017
- First submitted
- 14 Sep 2012
- Last updated
- 13 Jul 2017
- Results posted
- No
Publications
Glatz M, Juricevic N, Altwegg M, Bruisten S, Komericki P, Lautenschlager S, Weber R, Bosshard PP. A multicenter prospective trial to asses a new real-time polymerase chain reaction for detection of Treponema pallidum, herpes simplex-1/2 and Haemophilus ducreyi in genital, anal and oropharyngeal ulcers. Clin Microbiol Infect. 2014 Dec;20(12):O1020-7. doi: 10.1111/1469-0691.12710. Epub 2014 Jul 25.
PubMed 24909546
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01688258
- Acronym / sponsor ID
- GUD-PCR
- Conditions
- Genital Ulcer Disease (GUD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 19 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
(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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with genital, anal or oropharyngeal ulcers
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Antibiotic therapy within 2 weeks before the visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic swab | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
- Derived from this study: PubMed 24909546Glatz M, Juricevic N, Altwegg M, Bruisten S, Komericki P, Lautenschlager S, Weber R, Bosshard PP. A multicenter prospective trial to asses a new real-time polymerase chain reaction for detection of Treponema pallidum, herpes simplex-1/2 and Haemophilus ducreyi in genital, anal and oropharyngeal ulcers. Clin Microbiol Infect. 2014 Dec;20(12):O1020-7. doi: 10.1111/1469-0691.12710. Epub 2014 Jul 25.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philipp Bosshard, PhD principal investigator
University Hospital Zurich, Division of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genital Ulcer Disease (GUD), run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01688258, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2017.