InfluenzaFLUA+BNCT00636662
FLU A+B Nasal Swab Clinical Study
An observational study of Influenza, run by Response Biomedical Corp. at 5 sites in 2 countries.
Trial summary
The purpose of this clinical study is to obtain clearance for the nasal swab sample type by demonstrating the performance characteristics of the FLU A+B Test versus standard laboratory culture for Influenza A and B viruses using nasal swab samples. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Influenza
- What is being tested?
- Non-invasive diagnostic testing
- How many people
- 800 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Feb 2008to May 2008
- 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: Nasal swab samples will be collected from subjects suspected of having influenza infections and onset has occurred within 3 days of examination. Across the sites these samples will be drawn from an approximately 60% pediatric patients (<21 years), and 40% adult patients (>21 years) and it is expected that the population will be divided approximately equally between males and females.
Who may be able to join
- Male and Female of all age groups
- Patients exhibiting influenza symptoms (i.e., fever, body aches, headaches, cough, sore throat, and other respiratory symptoms) at the time of examination
- Patients must either present with a fever (>100ºF; >37.8ºC) at time of examination or have had a fever (>100ºF; >37.8ºC) or declare at time of the examination that they had a fever within the previous 3 days prior to the examination
- Must be able to collect sample using the nasal swab sample type
Who cannot join
- Patients with no fever at time of examination or within the 3 days prior to examination and/or are currently undergoing treatment (including anti-virals) will be excluded from the study.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Dell Children's Hospital
Austin, Texas
Northwestern University
Chicago, Illinois
Washington University / St. Louis Children's Hospital
St Louis, Missouri
Wake Forest University Health Sciences
Winston-Salem, North Carolina
About this study
Official title: Evaluation of the RAMP FLU A+B Test Versus Viral Culture Using Clinical Nasal Swab Samples From Patients With Suspected Influenza Infections
The purpose of this clinical study is to obtain clearance for the nasal swab sample type by demonstrating the performance characteristics of the FLU A+B Test versus standard laboratory culture for Influenza A and B viruses using nasal swab samples.
Read the detailed description
Patients exhibiting symptoms of influenza enrolled in a fashion that confidentiality of all personal health information is maintained.
No patient treatment is affected by enrollment in this trial.
- Conditions
- Influenza
- Being tested
- Non-invasive diagnostic testing
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive diagnostic testingOther
No patient treatment is altered by enrollment in this trial
| Study group | Role | What they receive |
|---|---|---|
| all | any patient exhibiting symptoms of influenza Receives: Other: Non-invasive diagnostic testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Support the addition of nasal swab sample type to labeling for the FLU A+B Test. The nasal swab sample data will be analyzed for the FLU A+B Test versus standard laboratory culture identification to determine the sensitivity and specificity.
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 posted14 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies 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
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Response Biomedical Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636662
- Sponsor's protocol ID
- CSP012
- Acronym
- FLUA+B
- Status last verified
- Mar 2019
- First submitted
- 7 Mar 2008
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the RAMP FLU A+B Test Versus Viral Culture Using Clinical Nasal Swab Samples From Patients With Suspected Influenza Infections
- ClinicalTrials.gov ID
- NCT00636662
- Acronym / sponsor ID
- FLUA+B / CSP012
- Conditions
- Influenza
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Response Biomedical Corp.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 14 Mar 2008 (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 purpose of this clinical study is to obtain clearance for the nasal swab sample type by demonstrating the performance characteristics of the FLU A+B Test versus standard laboratory culture for Influenza A and B viruses using nasal swab samples.
Detailed description
Patients exhibiting symptoms of influenza enrolled in a fashion that confidentiality of all personal health information is maintained.
No patient treatment is affected by enrollment in this trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all | – | Other: Non-invasive diagnostic testingany patient exhibiting symptoms of influenza |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Nasal swab samples will be collected from subjects suspected of having influenza infections and onset has occurred within 3 days of examination. Across the sites these samples will be drawn from an approximately 60% pediatric patients (<21 years), and 40% adult patients (>21 years) and it is expected that the population will be divided approximately equally between males and females.
Key inclusion criteria (4 listed)
- Male and Female of all age groups
- Patients exhibiting influenza symptoms (i.e., fever, body aches, headaches, cough, sore throat, and other respiratory symptoms) at the time of examination
- Patients must either present with a fever (>100ºF; >37.8ºC) at time of examination or have had a fever (>100ºF; >37.8ºC) or declare at time of the examination that they had a fever within the previous 3 days prior to the examination
- Must be able to collect sample using the nasal swab sample type
Key exclusion criteria (1 listed)
- Patients with no fever at time of examination or within the 3 days prior to examination and/or are currently undergoing treatment (including anti-virals) will be excluded from the study.
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 |
|---|---|---|
| Non-invasive diagnostic testingNo patient treatment is altered by enrollment in this trial | Other | all |
Primary outcome
Support the addition of nasal swab sample type to labeling for the FLU A+B Test. The nasal swab sample data will be analyzed for the FLU A+B Test versus standard laboratory culture identification to determine the sensitivity and specificity.
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 27 Mar 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, run by Response Biomedical Corp. at 5 sites in 2 countries.
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 4 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 27 Mar 2019. 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, Canada. 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?
Support the addition of nasal swab sample type to labeling for the FLU A+B Test. The nasal swab sample data will be analyzed for the FLU A+B Test versus standard laboratory culture identification to determine the sensitivity and specificity. (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 27 Mar 2019.