- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03772769
Diagnostic Modalities for Severe Odontogenic Infections Using Rapid, Target Enriched Multiplex PCR (TEM- PCR) by Diatherix
March 1, 2020 updated by: Nagi Demian, The University of Texas Health Science Center, Houston
Diagnostic Modalities for Severe Odontogenic Infections Using Rapid, Target Enriched Multiplex PCR (TEM- PCR)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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Houston, Texas, United States, 77030
- Th University of Texas Health Science Center at Houston
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Subjects with advanced deep space odontogenic infection
Subjects will be diagnosed via two methods: 1. Target Enriched Multiplex PCR (TEM- PCR) and 2. Standard microbial culture.
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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.
Standard diagnosis by microbial culture.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
Baseline (at the time the sample was obtained from the patient)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jonathon Jundt, DDS, MD, The University of Texas Health Science Center, Houston
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 1, 2019
Primary Completion (ACTUAL)
February 1, 2020
Study Completion (ACTUAL)
February 29, 2020
Study Registration Dates
First Submitted
December 7, 2018
First Submitted That Met QC Criteria
December 7, 2018
First Posted (ACTUAL)
December 11, 2018
Study Record Updates
Last Update Posted (ACTUAL)
March 3, 2020
Last Update Submitted That Met QC Criteria
March 1, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC-DB-18-0506
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Odontogenic Deep Space Neck Infection
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Clinical Trials on Target Enriched Multiplex PCR (TEM- PCR)
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Centre Hospitalier Universitaire, AmiensCompletedAcute Myeloid LeukemiaFrance
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Assistance Publique - Hôpitaux de ParisBiofireCompletedAcute Diarrhea | Acute Colitis of Presumed Infectious OriginFrance
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Diatherix Laboratories, LLCSuspended
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Avicenna Military HospitalCompletedHospital-acquired Pneumonia | Ventilator Associated Pneumonia | Community-acquired PneumoniaMorocco