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

Not Applicable

Completed

• Conditions: Odontogenic Deep Space Neck Infection

• Registration Number: NCT03772769
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-07
• Study First Submitted QC: 2018-12-07
• Study First Posted: 2018-12-11
• Study Start: 2019-02-01
• Primary Completion: 2020-02-01
• Study Completion: 2020-02-29
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-01
• Last Update Posted: 2020-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Th University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States