Pharyngitis BacterialNCT03037957
A Multi-Site Clinical Evaluation of the ARIES Group A Strep Assay in Symptomatic Patients
An observational study of Pharyngitis Bacterial, run by Luminex Corporation at 5 sites in United States.
Trial summary
A multi-center evaluation to assess the diagnostic sensitivity and specificity of the ARIES Group A Strep Assay will be established through a method comparison using prospectively collected, de-identified, clinical samples collected during the enrollment period. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pharyngitis Bacterial
- What is being tested?
- ARIES Group A Strep Assay
- Type of treatment
- Medical device
- How many people
- 704 participants
- Where
- 5 sitesUnited States
- Study dates
- 9 Jan 2017to 2 Jun 2017
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients presenting with signs and symptoms of pharyngitis for which their doctors ordered a Group A Strep test.
Who may be able to join
- Patient and/or patient's legal guardian is willing and able to give informed consent and/or assent for extra research sample.
- The subject's specimen is a throat swab in Liquid Amies based transport medium.
- The specimen is from an adult or pediatric, male or female subject who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinical or resident of a long term care facility.
- The specimen is from a patient for whom a requisition has been made for Group A Strep testing
- The specimen is from a patient exhibiting clinical signs and symptoms of pharyngitis consistent with Group A Strep infection.
- The specimen was received in good condition (no leakage or drying of the specimen).
- The specimen volume is ≥ 850 µL.
Who cannot join
- The specimen is from a patient who did not provide informed consent/assent.
- The specimen is not a throat swab collected in Liquid Amies based transport medium.
- The specimen is from a patient who is undergoing antibiotic treatment.
- The specimen was not properly collected, transported, processed or stored according to the instructions provided by the Sponsor in Section 9 below.
- The specimen volume is < 850 µL.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Children's Mercy Hospital
Kansas City, Missouri, 54449
Children's Hospital Los Angeles
Los Angeles, California, 90027
Marshfield Labs
Marshfield, Wisconsin, 54449
Sacred Heart Hospital
Pensacola, Florida, 32504
Advanced Pediatrics Research
Vienna, Virginia, 22180
About this study
A multi-center evaluation to assess the diagnostic sensitivity and specificity of the ARIES Group A Strep Assay will be established through a method comparison using prospectively collected, de-identified, clinical samples collected during the enrollment period.
- Conditions
- Pharyngitis Bacterial
- Being tested
- ARIES Group A Strep Assay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARIES Group A Strep AssayDevice
| Study group | Role | What they receive |
|---|---|---|
| Group A Strep Assay | Not described Receives: Device: ARIES Group A Strep Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance (sensitivity/specificity) for Group A Strep Assay
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start9 Jan 2017
- Primary completion2 Jun 2017
- Study completion2 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharyngitis BacterialStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 704 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luminex Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronald Dunn, Study director, Luminex Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037957
- Sponsor's protocol ID
- LMA-GAS-01-CS-006
- Status last verified
- Jul 2017
- First submitted
- 3 Jan 2017
- Last updated
- 7 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Site Clinical Evaluation of the ARIES Group A Strep Assay in Symptomatic Patients
- ClinicalTrials.gov ID
- NCT03037957
- Acronym / sponsor ID
- LMA-GAS-01-CS-006
- Conditions
- Pharyngitis Bacterial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 704 participants (actual)
- Lead sponsor
- Luminex CorporationIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- 2 Jun 2017 (actual)
- Study completion
- 2 Jun 2017 (actual)
- First posted
- 31 Jan 2017 (estimated)
- 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.
A multi-center evaluation to assess the diagnostic sensitivity and specificity of the ARIES Group A Strep Assay will be established through a method comparison using prospectively collected, de-identified, clinical samples collected during the enrollment period.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A Strep Assay | – | Device: ARIES Group A Strep Assay |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients presenting with signs and symptoms of pharyngitis for which their doctors ordered a Group A Strep test.
Key inclusion criteria (7 listed)
- Patient and/or patient's legal guardian is willing and able to give informed consent and/or assent for extra research sample.
- The subject's specimen is a throat swab in Liquid Amies based transport medium.
- The specimen is from an adult or pediatric, male or female subject who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinical or resident of a long term care facility.
- The specimen is from a patient for whom a requisition has been made for Group A Strep testing
- The specimen is from a patient exhibiting clinical signs and symptoms of pharyngitis consistent with Group A Strep infection.
Key exclusion criteria (5 listed)
- The specimen is from a patient who did not provide informed consent/assent.
- The specimen is not a throat swab collected in Liquid Amies based transport medium.
- The specimen is from a patient who is undergoing antibiotic treatment.
- The specimen was not properly collected, transported, processed or stored according to the instructions provided by the Sponsor in Section 9 below.
- The specimen volume is < 850 µL.
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 |
|---|---|---|
| ARIES Group A Strep Assay | Device | Group A Strep Assay |
Primary outcome
Clinical performance (sensitivity/specificity) for Group A Strep Assay
Time frame: Day 1
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 7 Jul 2017.
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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.
Ronald Dunn study director
Luminex Corporation
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pharyngitis Bacterial, run by Luminex Corporation at 5 sites 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 7 inclusion and 5 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 7 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Clinical performance (sensitivity/specificity) for Group A Strep Assay (time frame: Day 1). 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 7 Jul 2017.