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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03772769
Recruitment Status : Completed
First Posted : December 11, 2018
Last Update Posted : March 3, 2020
Sponsor:
Collaborator:
Eurofins
Information provided by (Responsible Party):
Nagi Demian, 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.

Condition or disease Intervention/treatment Phase
Odontogenic Deep Space Neck Infection Diagnostic Test: Target Enriched Multiplex PCR (TEM- PCR) Diagnostic Test: Microbial culture Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : February 1, 2019
Actual Primary Completion Date : February 1, 2020
Actual Study Completion Date : February 29, 2020

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.




Primary Outcome Measures :
  1. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772769


Locations
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United States, Texas
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
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Principal Investigator: Jonathon Jundt, DDS, MD The University of Texas Health Science Center, Houston
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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: December 11, 2018    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases