Ignite Creation Date:
2025-12-24 @ 11:11 PM
Ignite Modification Date:
2026-02-24 @ 2:09 PM
Study NCT ID:
NCT03772769
Status:
COMPLETED
Last Update Posted:
2020-03-03
First Post:
2018-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Modalities for Severe Odontogenic Infections Using Rapid, Target Enriched Multiplex PCR (TEM- PCR) by Diatherix
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-02-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-01', 'studyFirstSubmitDate': '2018-12-07', 'studyFirstSubmitQcDate': '2018-12-07', 'lastUpdatePostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Specificity as assessed by number of participants who had matching results between TEM-PCR and standard microbial culture', 'timeFrame': 'Baseline (at the time the sample was obtained from the patient)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Odontogenic Deep Space Neck Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the sensitivity and specificity of the Target Enriched Multiplex (TEM) polymerase chain reaction (PCR) platform for the rapid molecular diagnosis and treatment of odontogenic deep space neck infections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients in whom there is clinical and radiographic evidence of an odontogenic deep space neck infection.\n\nExclusion Criteria:\n\n* Patients with gross communication between the abscess and the oral cavity will be excluded.'}, 'identificationModule': {'nctId': 'NCT03772769', 'briefTitle': 'Diagnostic Modalities for Severe Odontogenic Infections Using Rapid, Target Enriched Multiplex PCR (TEM- PCR) by Diatherix', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Diagnostic Modalities for Severe Odontogenic Infections Using Rapid, Target Enriched Multiplex PCR (TEM- PCR)', 'orgStudyIdInfo': {'id': 'HSC-DB-18-0506'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subjects with advanced deep space odontogenic infection', 'description': 'Subjects will be diagnosed via two methods: 1. Target Enriched Multiplex PCR (TEM- PCR) and 2. Standard microbial culture.', 'interventionNames': ['Diagnostic Test: Target Enriched Multiplex PCR (TEM- PCR)', 'Diagnostic Test: Microbial culture']}], 'interventions': [{'name': 'Target Enriched Multiplex PCR (TEM- PCR)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Target Enriched Multiplex PCR (TEM- PCR) assays will be performed and will probe for the typical array of advanced deep space odontogenic infections, as well as MRSA resistance, clindamycin resistance, and the presence of Panton-Valentine leukocidin (PVL) toxin, a toxin produced by some bacteria.', 'armGroupLabels': ['Subjects with advanced deep space odontogenic infection']}, {'name': 'Microbial culture', 'type': 'DIAGNOSTIC_TEST', 'description': 'Standard diagnosis by microbial culture.', 'armGroupLabels': ['Subjects with advanced deep space odontogenic infection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Th University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Jonathon Jundt, DDS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eurofins', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Nagi Demian', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}