Influenza ANCT02067286
Detection of Influenza A, Influenza B, and RSV Using the Liat™ Assays on the Liat™ Analyzer
An observational study of Influenza A and Influenza B, run by IQuum, Inc. at 8 sites in United States.
Trial summary
The objective of this study is to evaluate the clinical sensitivity and specificity of the Liat™ Influenza A/B \& RSV Assay and the Liat™ Influenza A/B Assay when used on the Liat Analyzer to detect the presence or absence of Influenza A, Influenza B, and RSV in a nasopharyngeal swab specimen as compared to an FDA… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Influenza A, Influenza B, Respiratory Syncytial Virus (RSV)
- How many people
- 1,642 participants
- Where
- 8 sitesUnited States
- Study dates
- Jan 2014to Apr 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: Subjects must be exhibiting symptoms characteristic of influenza or RSV
Who may be able to join
- Patients exhibiting 2 or more symptom groups characteristic of influenza and/or RSV at the time of visit or within the past 48 hours:
- fever of at least 37.8 C (100F)
- runny or stuffy nose
- coughing, wheezing or difficulty breathing
- sore throat, headache, extreme tiredness, or muscle aches
- infants: decreased activity, irritability, poor feeding
- Subject who are able to understand and consent to participation; for minors under the age of 18, this includes a parent or legal guardian
Who cannot join
- Patients who are under-going anti-viral medication now or within the last 7 days.
- Patients who received Nasal Spray Flu Vaccine within the last 6 weeks
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Meridian Clinical Research
Bellevue, Nebraska, 68005
Cleveland Clinic
Cleveland, Ohio
Pediatrics-by-the-Sea
Delray Beach, Florida, 33483
Accurate Clinical Research
Houston, Texas, 77034
Northpoint Pediatrics
Indianapolis, Indiana, 46256
Plano Pediatrics
Plano, Texas, 75093
Meridian Clinical Research
Savannah, Georgia, 31406
Advanced Pediatrics
Vienna, Virginia, 22180
About this study
Official title: Multi-Center Study of In Vitro Diagnostic Devices for the Detection of Influenza A, Influenza B, and RSV
The objective of this study is to evaluate the clinical sensitivity and specificity of the Liat™ Influenza A/B \& RSV Assay and the Liat™ Influenza A/B Assay when used on the Liat Analyzer to detect the presence or absence of Influenza A, Influenza B, and RSV in a nasopharyngeal swab specimen as compared to an FDA approved NAAT and culture.
- Conditions
- Influenza A, Influenza B, Respiratory Syncytial Virus (RSV)
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the sensitivity and specificity of the Liat™ Influenza A/B & RSV Assay and the Liat™ Influenza A/B Assay as compared to an FDA-cleared nucleic acid amplification test
Measured: 1 day
Secondary outcomes (1)
Evaluate the sensitivity and specificity of the Liat™ Influenza A/B & RSV Assay and the Liat™ Influenza A/B Assay as compared to culture
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza AStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,642 participants (actual)
Sponsor and investigators
- Lead sponsor
- IQuum, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Roche Molecular Systems, Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067286
- Sponsor's protocol ID
- FR4, Rev. 3.3
- Status last verified
- Aug 2016
- First submitted
- 14 Feb 2014
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Study of In Vitro Diagnostic Devices for the Detection of Influenza A, Influenza B, and RSV
- ClinicalTrials.gov ID
- NCT02067286
- Acronym / sponsor ID
- FR4, Rev. 3.3
- Conditions
- Influenza A, Influenza B, Respiratory Syncytial Virus (RSV)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,642 participants (actual)
- Lead sponsor
- IQuum, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Roche Molecular Systems, Inc
- Study start
- Jan 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 20 Feb 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 objective of this study is to evaluate the clinical sensitivity and specificity of the Liat™ Influenza A/B \& RSV Assay and the Liat™ Influenza A/B Assay when used on the Liat Analyzer to detect the presence or absence of Influenza A, Influenza B, and RSV in a nasopharyngeal swab specimen as compared to an FDA approved NAAT and culture.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects must be exhibiting symptoms characteristic of influenza or RSV
Key inclusion criteria (7 listed)
- Patients exhibiting 2 or more symptom groups characteristic of influenza and/or RSV at the time of visit or within the past 48 hours:
- Subject who are able to understand and consent to participation; for minors under the age of 18, this includes a parent or legal guardian
Key exclusion criteria (2 listed)
- Patients who are under-going anti-viral medication now or within the last 7 days.
- Patients who received Nasal Spray Flu Vaccine within the last 6 weeks
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
Evaluate the sensitivity and specificity of the Liat™ Influenza A/B & RSV Assay and the Liat™ Influenza A/B Assay as compared to an FDA-cleared nucleic acid amplification test
Time frame: 1 day
1 secondary outcome
Evaluate the sensitivity and specificity of the Liat™ Influenza A/B & RSV Assay and the Liat™ Influenza A/B Assay as compared to culture
Time frame: 1 day
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 31 Aug 2016.
- Individual participant dataSharing planned: No
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Healthy Participants
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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza A and Influenza B, run by IQuum, Inc. at 8 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 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: finished, as of the sponsor's last update on 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Evaluate the sensitivity and specificity of the Liat™ Influenza A/B & RSV Assay and the Liat™ Influenza A/B Assay as compared to an FDA-cleared nucleic acid amplification test (time frame: 1 day). 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 31 Aug 2016.