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

Odontogenic Deep Space Neck Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03772769
• Other study ID #: HSC-DB-18-0506
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: February 29, 2020

Study information

• Verified date: March 2020
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 29, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Odontogenic Deep Space Neck Infection

Intervention

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.
• Microbial culture
Standard diagnosis by microbial culture.

Locations

Country	Name	City	State
United States	Th University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Eurofins

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specificity as assessed by number of participants who had matching results between TEM-PCR and standard microbial culture		Baseline (at the time the sample was obtained from the patient)