Diagnostic Modalities for Severe Odontogenic Infections Using Rapid, Target Enriched Multiplex PCR (TEM- PCR) by Diatherix

Purpose

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.

Condition

  • Odontogenic Deep Space Neck Infection

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

More Details

Status
Completed
Sponsor
The University of Texas Health Science Center, Houston

Study Contact