Influenza HumanNCT00863343
Clinical Validation of the Point-of-Care MSD Influenza Test
An observational study of Influenza Human, run by Meso Scale Diagnostics, LLC. at 3 sites in United States.
Trial summary
The primary objective of this study is to evaluate the performance of the MSD® Influenza Test in detecting influenza A and influenza B in subjects presenting with influenza-like-illness (ILI). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Influenza Human
- What is being tested?
- Public Health Notification
- How many people
- 391 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2010to Aug 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Individuals visiting a primary care site.
Who may be able to join
- Any subject (all ages) presenting with ILI (defined as fever [subjective or documented] and cough or sore throat), and suspected of having influenza.
- Subject (parent, guardian, or authorized legal representative) gives informed consent or assent (child) to the study, and provides signed authorization for use and disclosure of protected health information.
Who cannot join
- Any subject classified as "high risk" for exposure to avian or novel influenza, as determined by a Risk-Assessment Questionnaire.
- Subjects who had prior nasal wash/aspirate or nasopharyngeal wash/aspirate specimens collected for routine health-care purposes within the same suspected influenza infection episode.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
John T Mather Hospital
Port Jefferson, New York, 11777
Naval Health Research Center
San Diego, California, 92106
About this study
The primary objective of this study is to evaluate the performance of the MSD® Influenza Test in detecting influenza A and influenza B in subjects presenting with influenza-like-illness (ILI).
Read the detailed description
This is a multicenter, prospective study to evaluate the performance of the MSD Influenza Test for the detection and differentiation of influenza A (including A/H1, A/H3, and A/H5 subtypes) and influenza B. Nasal swabs from subjects presenting at the clinical care facility with ILI will be collected and tested on the MSD Influenza Test. Results from the Test will be compared to results obtained from viral culture performed on a second nasal swab at a reference laboratory.
- Conditions
- Influenza Human
- Being tested
- Public Health Notification
- Keywords
- Influenza infections, Orthomyxoviridae infections
- Medical subject headings
- Influenza, Human, Orthomyxoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Public Health NotificationBiological
For any H5 positive results, notification of the result to the site's local public health authorities.
| Study group | Role | What they receive |
|---|---|---|
| All | Anyone presenting with influenza-like-illness Receives: Biological: Public Health Notification |
What is being measured
The primary outcome is the main question the study is designed to answer.
MSD Influenza A Test Results Against Cell Culture
A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared.
Measured: 1 day
MSD Influenza B Test Results Against Cell Culture
A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences.
Measured: 1 day
MSD Influenza A Test Results Against Culture and PCR
A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences.
Measured: 1 day
MSD Influenza B Test Results Against Culture and PCR
A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences.
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 posted18 Mar 2009 (estimated)
- Study startMar 2010
- Primary completionJul 2010
- Study completionAug 2010
Why it stopped: Funding of study was exhausted prior to completion of study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Influenza HumanStudies 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
- 391 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meso Scale Diagnostics, LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Jacqueline Perodin, PhD, CCRP, Study director, Meso Scale Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00863343
- Sponsor's protocol ID
- MSD-ITPOC-01
- Status last verified
- Jan 2012
- First submitted
- 16 Mar 2009
- Last updated
- 1 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of the Point-of-Care MSD Influenza Test
- ClinicalTrials.gov ID
- NCT00863343
- Acronym / sponsor ID
- MSD-ITPOC-01
- Conditions
- Influenza Human
- Keywords
- Influenza infections, Orthomyxoviridae infections
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funding of study was exhausted prior to completion of study
- Enrolment
- 391 participants (actual)
- Lead sponsor
- Meso Scale Diagnostics, LLC.Industry (pharma, biotech, devices)
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Mar 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 18 Mar 2009 (estimated)
- Results
- Posted 1 Mar 2012
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 performance of the MSD® Influenza Test in detecting influenza A and influenza B in subjects presenting with influenza-like-illness (ILI).
Detailed description
This is a multicenter, prospective study to evaluate the performance of the MSD Influenza Test for the detection and differentiation of influenza A (including A/H1, A/H3, and A/H5 subtypes) and influenza B. Nasal swabs from subjects presenting at the clinical care facility with ILI will be collected and tested on the MSD Influenza Test. Results from the Test will be compared to results obtained from viral culture performed on a second nasal swab at a reference laboratory.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All | – | Biological: Public Health NotificationAnyone presenting with influenza-like-illness |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals visiting a primary care site.
Key inclusion criteria (2 listed)
- Any subject (all ages) presenting with ILI (defined as fever [subjective or documented] and cough or sore throat), and suspected of having influenza.
- Subject (parent, guardian, or authorized legal representative) gives informed consent or assent (child) to the study, and provides signed authorization for use and disclosure of protected health information.
Key exclusion criteria (2 listed)
- Any subject classified as "high risk" for exposure to avian or novel influenza, as determined by a Risk-Assessment Questionnaire.
- Subjects who had prior nasal wash/aspirate or nasopharyngeal wash/aspirate specimens collected for routine health-care purposes within the same suspected influenza infection episode.
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 |
|---|---|---|
| Public Health NotificationFor any H5 positive results, notification of the result to the site's local public health authorities. | Biological | All |
Primary outcome
MSD Influenza A Test Results Against Cell Culture
Time frame: 1 day
A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared.
MSD Influenza B Test Results Against Cell Culture
Time frame: 1 day
A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences.
MSD Influenza A Test Results Against Culture and PCR
Time frame: 1 day
A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences.
MSD Influenza B Test Results Against Culture and PCR
Time frame: 1 day
A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jacqueline Perodin, PhD, CCRP study director
Meso Scale Diagnostics
3 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 Human, run by Meso Scale Diagnostics, LLC. at 3 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 2 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: stopped early, as of the sponsor's last update on 1 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 1 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
MSD Influenza A Test Results Against Cell Culture (time frame: 1 day). The study lists 4 primary outcomes in all. 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 1 Mar 2012.