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

The University of Texas Health Science Center, Houston30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Odontogenic Deep Space Neck Infection

Interventions

Target Enriched Multiplex PCR (TEM- PCR)DIAGNOSTIC_TEST

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.

Microbial cultureDIAGNOSTIC_TEST

Standard diagnosis by microbial culture.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Th University of Texas Health Science Center at Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

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)

Data from ClinicalTrials.gov

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