Back to resultsDiagnostic Modalities for Severe Odontogenic Infections Using Rapid, Target Enriched Multiplex PCR (TEM- PCR) by Diatherix
Primary Purpose
Odontogenic Deep Space Neck Infection
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Target Enriched Multiplex PCR (TEM- PCR)
Microbial culture
Sponsored by
About this trial
This is an interventional diagnostic trial for Odontogenic Deep Space Neck Infection
Eligibility Criteria
Inclusion Criteria:
- Patients in whom there is clinical and radiographic evidence of an odontogenic deep space neck infection.
Exclusion Criteria:
- Patients with gross communication between the abscess and the oral cavity will be excluded.
Sites / Locations
- Th University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subjects with advanced deep space odontogenic infection
Arm Description
Subjects will be diagnosed via two methods: 1. Target Enriched Multiplex PCR (TEM- PCR) and 2. Standard microbial culture.
Outcomes
Primary Outcome Measures
Specificity as assessed by number of participants who had matching results between TEM-PCR and standard microbial culture
Secondary Outcome Measures
Full Information
NCT ID
NCT03772769
First Posted
December 7, 2018
Last Updated
March 1, 2020
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Eurofins
1. Study Identification
Unique Protocol Identification Number
NCT03772769
Brief Title
Diagnostic Modalities for Severe Odontogenic Infections Using Rapid, Target Enriched Multiplex PCR (TEM- PCR) by Diatherix
Official Title
Diagnostic Modalities for Severe Odontogenic Infections Using Rapid, Target Enriched Multiplex PCR (TEM- PCR)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
February 29, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Eurofins
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Odontogenic Deep Space Neck Infection
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects with advanced deep space odontogenic infection
Arm Type
Experimental
Arm Description
Subjects will be diagnosed via two methods: 1. Target Enriched Multiplex PCR (TEM- PCR) and 2. Standard microbial culture.
Intervention Type
Diagnostic Test
Intervention Name(s)
Target Enriched Multiplex PCR (TEM- PCR)
Intervention 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Microbial culture
Intervention Description
Standard diagnosis by microbial culture.
Primary Outcome Measure Information:
Title
Specificity as assessed by number of participants who had matching results between TEM-PCR and standard microbial culture
Time Frame
Baseline (at the time the sample was obtained from the patient)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients in whom there is clinical and radiographic evidence of an odontogenic deep space neck infection.
Exclusion Criteria:
Patients with gross communication between the abscess and the oral cavity will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathon Jundt, DDS, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Th University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Diagnostic Modalities for Severe Odontogenic Infections Using Rapid, Target Enriched Multiplex PCR (TEM- PCR) by Diatherix
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