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

• Sponsor: The University of Texas Health Science Center, Houston (Other)
• Overall Status: Completed
• CT.gov ID: NCT03772769
• Collaborator: Eurofins (Industry)
• Enrollment: 30
• Location: 1
• Arm: 1
• Actual Duration (Months): 12.9
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Odontogenic Deep Space Neck Infection	Diagnostic Test: Target Enriched Multiplex PCR (TEM- PCR); Diagnostic Test: Microbial culture	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Diagnostic Modalities for Severe Odontogenic Infections Using Rapid, Target Enriched Multiplex PCR (TEM- PCR)
• Actual Study Start Date: Feb 1, 2019
• Actual Primary Completion Date: Feb 1, 2020
• Actual Study Completion Date: Feb 29, 2020

Arms and Interventions

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

1. 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)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Th University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

• The University of Texas Health Science Center, Houston
• Eurofins

Investigators

• Principal Investigator: Jonathon Jundt, DDS, MD, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nagi Demian, Clinical Assistant Professor, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT03772769
• Other Study ID Numbers: HSC-DB-18-0506
• First Posted: Dec 11, 2018
• Last Update Posted: Mar 3, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases

Study Results

No Results Posted as of Mar 3, 2020