Completed

NCT Number: NCT03772769

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

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.

Completed

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Key information

Conditions

Odontogenic Deep Space Neck Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Th University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 culture

Diagnostic Test

Standard diagnosis by microbial culture.

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)

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

Eurofins

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Dec 11, 2018
Registry last updated: Mar 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.