Diagnostic Modalities for Severe Odontogenic Infections Using Rapid, Target Enriched Multiplex PCR (TEM- PCR) by Diatherix
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03772769|
Recruitment Status : Completed
First Posted : December 11, 2018
Last Update Posted : March 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Odontogenic Deep Space Neck Infection||Diagnostic Test: Target Enriched Multiplex PCR (TEM- PCR) Diagnostic Test: Microbial culture||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diagnostic Modalities for Severe Odontogenic Infections Using Rapid, Target Enriched Multiplex PCR (TEM- PCR)|
|Actual Study Start Date :||February 1, 2019|
|Actual Primary Completion Date :||February 1, 2020|
|Actual Study Completion Date :||February 29, 2020|
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.
Diagnostic Test: Target Enriched Multiplex PCR (TEM- PCR)
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.
Diagnostic Test: Microbial culture
Standard diagnosis by microbial culture.
- 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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772769
|United States, Texas|
|Th University of Texas Health Science Center at Houston|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Jonathon Jundt, DDS, MD||The University of Texas Health Science Center, Houston|