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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03772769
Enrollment
30
Registered
2018-12-11
Start date
2019-02-01
Completion date
2020-02-29
Last updated
2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Odontogenic Deep Space Neck Infection

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.

Interventions

DIAGNOSTIC_TESTTarget 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_TESTMicrobial culture

Standard diagnosis by microbial culture.

Sponsors

Eurofins
CollaboratorINDUSTRY
The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
Specificity as assessed by number of participants who had matching results between TEM-PCR and standard microbial cultureBaseline (at the time the sample was obtained from the patient)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026