Acute GastroenteritisNCT02092259
A Multi-Site Clinical Evaluation of the ARIES Norovirus Assay
An observational study of Acute Gastroenteritis, run by Luminex Corporation at 5 sites in United States.
Trial summary
The ARIES Norovirus Assay is a real-time PCR based qualitative in vitro diagnostic test for the direct detection of Norovirus GI/GII RNA from stool specimens obtained from symptomatic patients. The purpose of this study is to establish the diagnostic accuracy of ARIES Norovirus Assay. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Gastroenteritis
- How many people
- 500 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2014to Dec 2015
- 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: All comers
Who may be able to join
- The specimen is from a patient with symptoms of acute gastroenteritis.
- The specimen is from a male or female subject who was either hospitalized, admitted to a hospital emergency department or visiting an outpatient clinic.
- The subject's specimen is an unpreserved, unformed (liquid or soft) stool submitted for testing at the site.
Who cannot join
- The specimen is from an individual with known and documented non-infectious conditions such as ulcerative colitis, irritable bowel syndrome and/or Crohn's disease
- The specimen was not properly collected, transported, processed or stored according to the instructions provided by the sponsor.
Trial locations and contacts
5 sites in 1 country.
Ian Ridd contact
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 13123
C. Robinson, Christine.Robinson@childrenscolorado.org
Christine Robinson, Ph.D
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Elena Popowitch, elena.popowitch@unchealth.unc.edu
Melissa Miller, Ph.D
- Recruiting
Geisinger Medical Laboratories
Danville, Pennsylvania, 17822-0131
D. Hernandez, drhernandez@geisinger.edu
Donna M Wolk, Ph.D.,D(ABMM)
- Recruiting
Indiana Health
Indianapolis, Indiana, 46202
Kristin Post, kpost@iuhealth.org
Liang Cheng, MD
- Recruiting
UCLA
Los Angeles, California, 90049
Janet Hindler, jhindler@mednet.ucla.edu
Romney Humphries, Ph.D
About this study
Official title: A Multi-Site Clinical Evaluation of the ARIES Norovirus Assay in Patients With Signs and Symptoms of Acute Gastroenteritis
The ARIES Norovirus Assay is a real-time PCR based qualitative in vitro diagnostic test for the direct detection of Norovirus GI/GII RNA from stool specimens obtained from symptomatic patients.
The purpose of this study is to establish the diagnostic accuracy of ARIES Norovirus Assay.
Read the detailed description
The ARIES Norovirus Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of Norovirus GI/GII RNA from stool specimens obtained from symptomatic patients.
The objective is to establish the diagnostic accuracy of the ARIES Norovirus assay through a multi-site, method comparison on prospectively collected leftover, stool specimens. Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement)
- Conditions
- Acute Gastroenteritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).
Accuracy determinations (diagnostic sensitivity and specificity, positive and negative agreement) were based on the fraction of comparator positive (or negative) results which were also positive (or negative) by ARIES Norovirus Assay.
Measured: Within the first year of sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute GastroenteritisStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luminex Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Himsworth, Study director, Luminex Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092259
- Sponsor's protocol ID
- LMA-NOR-01-CS-001
- Status last verified
- Jun 2015
- First submitted
- 17 Mar 2014
- Last updated
- 14 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Site Clinical Evaluation of the ARIES Norovirus Assay in Patients With Signs and Symptoms of Acute Gastroenteritis
- ClinicalTrials.gov ID
- NCT02092259
- Acronym / sponsor ID
- LMA-NOR-01-CS-001
- Conditions
- Acute Gastroenteritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Luminex CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (estimated)
- First posted
- 20 Mar 2014 (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.
The ARIES Norovirus Assay is a real-time PCR based qualitative in vitro diagnostic test for the direct detection of Norovirus GI/GII RNA from stool specimens obtained from symptomatic patients.
The purpose of this study is to establish the diagnostic accuracy of ARIES Norovirus Assay.
Detailed description
The ARIES Norovirus Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of Norovirus GI/GII RNA from stool specimens obtained from symptomatic patients.
The objective is to establish the diagnostic accuracy of the ARIES Norovirus assay through a multi-site, method comparison on prospectively collected leftover, stool specimens. Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All comers
Key inclusion criteria (3 listed)
- The specimen is from a patient with symptoms of acute gastroenteritis.
- The specimen is from a male or female subject who was either hospitalized, admitted to a hospital emergency department or visiting an outpatient clinic.
- The subject's specimen is an unpreserved, unformed (liquid or soft) stool submitted for testing at the site.
Key exclusion criteria (2 listed)
- The specimen is from an individual with known and documented non-infectious conditions such as ulcerative colitis, irritable bowel syndrome and/or Crohn's disease
- The specimen was not properly collected, transported, processed or stored according to the instructions provided by the sponsor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).
Time frame: Within the first year of sample collection
Accuracy determinations (diagnostic sensitivity and specificity, positive and negative agreement) were based on the fraction of comparator positive (or negative) results which were also positive (or negative) by ARIES Norovirus Assay.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2015.
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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.
Ian Ridd contact
David Himsworth 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 Acute Gastroenteritis, 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 14 Jul 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ian Ridd (iridd@luminexcorp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement). (time frame: Within the first year of sample collection). 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 14 Jul 2015.