UTHealth | Clinical Trials

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

Arm	Description	Assigned 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

Notice

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