Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT01688258
Status:
COMPLETED
Last Update Posted:
2017-07-13
First Post:
2012-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Multiplex Real-time PCR for Genital Ulcer Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-12', 'studyFirstSubmitDate': '2012-09-14', 'studyFirstSubmitQcDate': '2012-09-18', 'lastUpdatePostDateStruct': {'date': '2017-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Genital Ulcer Disease (GUD)']}, 'referencesModule': {'references': [{'pmid': '24909546', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '(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).\n\n(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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with genital, anal or oropharyngeal ulcers', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patient with genital, anal or oropharyngeal ulcers\n* Age minimum of 18 years.\n* Informed consent must be obtained from each patient/control patient in written form prior to any study procedure.\n\nExclusion criteria:\n\n* Antibiotic therapy within 2 weeks before the visit'}, 'identificationModule': {'nctId': 'NCT01688258', 'briefTitle': 'New Multiplex Real-time PCR for Genital Ulcer Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'GUD-PCR'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Diagnostic swab', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich, Division of Dermatology', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Philipp Bosshard, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zurich, Division of Dermatology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}