Odontogenic Deep Space Neck InfectionNCT03772769
Diagnostic Modalities for Severe Odontogenic Infections Using Rapid, Target Enriched Multiplex PCR (TEM- PCR) by Diatherix
A study testing Target Enriched Multiplex PCR (TEM- PCR) and Microbial culture in people with Odontogenic Deep Space Neck Infection, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Odontogenic Deep Space Neck Infection
- What is being tested?
- Target Enriched Multiplex PCR (TEM- PCR) and Microbial culture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 29 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in whom there is clinical and radiographic evidence of an odontogenic deep space neck infection.
Who cannot join
- Patients with gross communication between the abscess and the oral cavity will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Th University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Diagnostic Modalities for Severe Odontogenic Infections Using Rapid, Target Enriched Multiplex PCR (TEM- PCR)
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.
- Conditions
- Odontogenic Deep Space Neck Infection
- Being tested
- Target Enriched Multiplex PCR (TEM- PCR), Microbial culture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 cultureDiagnostic test
Standard diagnosis by microbial culture.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with advanced deep space odontogenic infection | Experimental | Subjects will be diagnosed via two methods: 1. Target Enriched Multiplex PCR (TEM- PCR) and 2. Standard microbial culture. Receives: Diagnostic Test: Target Enriched Multiplex PCR (TEM- PCR); Diagnostic Test: Microbial culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity as assessed by number of participants who had matching results between TEM-PCR and standard microbial culture
Measured: Baseline (at the time the sample was obtained from the patient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start1 Feb 2019
- Primary completion1 Feb 2020
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Odontogenic Deep Space Neck InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- Eurofins
- Responsible party
- Principal investigator, Nagi Demian, The University of Texas Health Science Center, Houston
- Investigators
- Jonathon Jundt, DDS, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772769
- Sponsor's protocol ID
- HSC-DB-18-0506
- Status last verified
- Mar 2020
- First submitted
- 7 Dec 2018
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Modalities for Severe Odontogenic Infections Using Rapid, Target Enriched Multiplex PCR (TEM- PCR)
- ClinicalTrials.gov ID
- NCT03772769
- Acronym / sponsor ID
- HSC-DB-18-0506
- Conditions
- Odontogenic Deep Space Neck Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Eurofins
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 11 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with advanced deep space odontogenic infection | Experimental | Diagnostic Test: Target Enriched Multiplex PCR (TEM- PCR), Diagnostic Test: Microbial cultureSubjects will be diagnosed via two methods: 1. Target Enriched Multiplex PCR (TEM- PCR) and 2. Standard microbial culture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients in whom there is clinical and radiographic evidence of an odontogenic deep space neck infection.
Key exclusion criteria (1 listed)
- Patients with gross communication between the abscess and the oral cavity will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Subjects with advanced deep space odontogenic infection |
| Microbial cultureStandard diagnosis by microbial culture. | Diagnostic test | Subjects with advanced deep space odontogenic infection |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathon Jundt, DDS, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Target Enriched Multiplex PCR (TEM- PCR) and Microbial culture in people with Odontogenic Deep Space Neck Infection, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.