InfluenzaPhase 3NCT00826709
Prospective Evaluation of the Fluid Rapid Influenza Test
A Phase 3 study testing fluID Rapid Influenza Test in people with Influenza, run by Nanogen, Inc. at 13 sites in 2 countries.
Trial summary
The primary objective of this study is to evaluate the fluID Rapid Influenza Test's ability in detecting influenza A and influenza B from individuals presenting with signs and symptoms of influenza-like illness (ILI). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Influenza
- What is being tested?
- fluID Rapid Influenza Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,300 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Feb 2009to Oct 2009
- Phase
- Phase 3
- 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
Who may be able to join
- Male or female subjects of any age;
- Subjects presenting to the investigative site within 4 days of symptom onset, with:
- Fever ≥ 38.0°C (100.4°F) if taken orally, or ≥ 38.5°C (101.2°F) if taken rectally; or a self-reported history of fever or feeling feverish (includes fever controlled by medication) in the absence of documented fever;
- One or more respiratory symptoms of influenza-like illness which may include the following:
- Sore throat;
- Runny or stuffy nose;
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- Cough;
- One or more constitutional symptoms of influenza-like illness which may include the following:
- Myalgia (aches and pains);
- Headache;
- Fatigue;
- Subjects (or parent/guardian) willing and able to provide informed consent. Written subject informed consent for this study protocol must be obtained prior to study enrollment. Each subject (or parent or guardian) must personally sign and date the Subject Informed Consent Form prior to his/her participation in this clinical study.
Who cannot join
- Subjects not presenting with at least three symptoms of influenza-like illness as outlined above.
- Subjects who have received influenza antiviral medication or an investigational influenza drug treatment within the previous 30 days of study enrollment.
- Subjects (children and adults) for whom the obtaining of swab samples, nasal wash or aspirate samples is contraindicated or not possible.
- Subjects with a medical condition that prevents swab samples or nasal washes or aspirate samples from being obtained.
- Active duty military personnel (participating military study sites only).
- Subjects (or parent/guardian) unwilling or unable to provide informed consent.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
New York Methodist Hospital
Brooklyn, New York, 11215
University Clinical Research - DeLand, LLC
DeLand, Florida, 32720
Sinai Grace Hospital
Detroit, Michigan, 48235
Children's Mercy Hospital
Kansas City, Missouri, 64108
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Naval Health Research Center
San Diego, California, 92152
Louisiana State University Health Sciences Center
Shreveport, Louisiana, 71103
The Family Doctor Research
Shreveport, Louisiana, 71115
Washington University at St. Louis
St Louis, Missouri, 63110
Granger Medical Clinic
West Valley City, Utah, 84015
Forsyth Medical Center
Winston-Salem, North Carolina, 27103
About this study
Official title: CLINICAL STUDY PROTOCOL for the Prospective Evaluation of the fluID Rapid Influenza Test
The primary objective of this study is to evaluate the fluID Rapid Influenza Test's ability in detecting influenza A and influenza B from individuals presenting with signs and symptoms of influenza-like illness (ILI).
Read the detailed description
The primary objective of this study is to evaluate the clinical sensitivity and specificity of the fluID Rapid Influenza Test in detecting influenza A and influenza B, as evaluated with respect to fresh samples collected prospectively from individuals presenting with signs and symptoms of influenza-like illness (ILI). Test results will be compared with those obtained from viral culture testing of samples using the same specimen types, obtained from the same subjects. The specimen types under evaluation in this study will be nasal swab, nasopharyngeal swab, nasal wash and aspirate specimens.
A secondary objective of this study is to evaluate the accuracy of the fluID Rapid Influenza Test in detecting each of the H1 and H3 subtypes of influenza A, in nasal swab, nasopharyngeal swab, nasal wash and aspirate specimens.
- Conditions
- Influenza
- Being tested
- fluID Rapid Influenza Test
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluID Rapid Influenza TestDevice
The fluID™ Rapid Influenza Test is an in vitro diagnostic assay designed to be used with a reader for the qualitative detection of influenza type A and type B nucleoprotein antigens, and the differentiation of influenza type A subtypes A/H1 and A/H3 antigens associated with the seasonal influenza H1N1 and H3N2, in nasal swabs, nasopharyngeal swabs and nasal wash/aspirate specimens. The test is intended as an aid in the rapid, qualitative diagnosis of influenza type A and type B viral infections in patients symptomatic with influenza-like illness. The fluID™ Rapid Influenza Test is intended for use by a healthcare professional in a laboratory or Point-of-Care (POC).
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 2 Nasal swabs Receives: Device: fluID Rapid Influenza Test |
| Arm 2 | Experimental | 2 Nasopharyngeal swabs Receives: Device: fluID Rapid Influenza Test |
| Arm 3 | Experimental | Nasal wash or aspirate Receives: Device: fluID Rapid Influenza Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of influenza A and influenza B
Measured: End of study
Secondary outcomes (1)
Sensitivity and specificity of influenza A subtypes H1N1 and H3N2
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionOct 2009 (estimated)
Why it stopped: The 2008-09 North American peak influenza season ended prior to study completion.
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanogen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826709
- Sponsor's protocol ID
- FLU-05
- Status last verified
- Apr 2009
- First submitted
- 20 Jan 2009
- Last updated
- 15 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLINICAL STUDY PROTOCOL for the Prospective Evaluation of the fluID Rapid Influenza Test
- ClinicalTrials.gov ID
- NCT00826709
- Acronym / sponsor ID
- FLU-05
- Conditions
- Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The 2008-09 North American peak influenza season ended prior to study completion.
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Nanogen, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Feb 2009
- Primary completion
- Oct 2009 (estimated)
- First posted
- 22 Jan 2009 (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 primary objective of this study is to evaluate the fluID Rapid Influenza Test's ability in detecting influenza A and influenza B from individuals presenting with signs and symptoms of influenza-like illness (ILI).
Detailed description
The primary objective of this study is to evaluate the clinical sensitivity and specificity of the fluID Rapid Influenza Test in detecting influenza A and influenza B, as evaluated with respect to fresh samples collected prospectively from individuals presenting with signs and symptoms of influenza-like illness (ILI). Test results will be compared with those obtained from viral culture testing of samples using the same specimen types, obtained from the same subjects. The specimen types under evaluation in this study will be nasal swab, nasopharyngeal swab, nasal wash and aspirate specimens.
A secondary objective of this study is to evaluate the accuracy of the fluID Rapid Influenza Test in detecting each of the H1 and H3 subtypes of influenza A, in nasal swab, nasopharyngeal swab, nasal wash and aspirate specimens.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Device: fluID Rapid Influenza Test2 Nasal swabs |
| Arm 2 | Experimental | Device: fluID Rapid Influenza Test2 Nasopharyngeal swabs |
| Arm 3 | Experimental | Device: fluID Rapid Influenza TestNasal wash or aspirate |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female subjects of any age;
- Subjects presenting to the investigative site within 4 days of symptom onset, with:
- Subjects (or parent/guardian) willing and able to provide informed consent. Written subject informed consent for this study protocol must be obtained prior to study enrollment. Each subject (or parent or guardian) must personally sign and date the Subject Informed Consent Form prior to his/her participation in this clinical study.
Key exclusion criteria (6 listed)
- Subjects not presenting with at least three symptoms of influenza-like illness as outlined above.
- Subjects who have received influenza antiviral medication or an investigational influenza drug treatment within the previous 30 days of study enrollment.
- Subjects (children and adults) for whom the obtaining of swab samples, nasal wash or aspirate samples is contraindicated or not possible.
- Subjects with a medical condition that prevents swab samples or nasal washes or aspirate samples from being obtained.
- Active duty military personnel (participating military study sites only).
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 |
|---|---|---|
| fluID Rapid Influenza TestThe fluID™ Rapid Influenza Test is an in vitro diagnostic assay designed to be used with a reader for the qualitative detection of influenza type A and type B nucleoprotein antigens, and the differentiation of influenza type A subtypes A/H1 and A/H3 antigens associated with the seasonal influenza H1N1 and H3N2, in nasal swabs, nasopharyngeal swabs and nasal wash/aspirate specimens. The test is intended as an aid in the rapid, qualitative diagnosis of influenza type A and type B viral infections in patients symptomatic with influenza-like illness. The fluID™ Rapid Influenza Test is intended for use by a healthcare professional in a laboratory or Point-of-Care (POC). | Device | Arm 1, Arm 2, Arm 3 |
Primary outcome
Sensitivity and specificity of influenza A and influenza B
Time frame: End of study
1 secondary outcome
Sensitivity and specificity of influenza A subtypes H1N1 and H3N2
Time frame: End of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2009.
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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.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing fluID Rapid Influenza Test in people with Influenza, run by Nanogen, Inc. at 13 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 12 inclusion and 6 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: paused, as of the sponsor's last update on 15 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Hong Kong. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Sensitivity and specificity of influenza A and influenza B (time frame: End of study). 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 15 Apr 2009.