InfluenzaNCT01089816
Rapid Diagnostic Test for Influenza
An observational study of Influenza, run by Meso Scale Diagnostics, LLC. at 4 sites in Vietnam.
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
- What is being tested?
- Local/Regional Public Health Notification
- How many people
- 569 participants
- Where
- 4 sitesVietnam
- Study dates
- Mar 2010to Oct 2010
- 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: Individuals visiting a health care facility.
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 to the study, and provides signed authorization for use and disclosure of protected health information.
Who cannot join
- 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.
- Unable to collect nasal and throat swab.
- Severely ill patient without a family relative to provide informed consent.
Trial locations and contacts
4 sites in 1 country.
Vietnam4 sites
National Hospital of Pediatrics
Hà Nội
Children's Hospital #2
Ho Chi Minh City
Children's Hospital 1
Ho Chi Minh City
Hospital for Tropical Diseases
Ho Chi Minh City
About this study
Official title: Clinical Validation of the Point-of-Care MSD Influenza Test in Asia
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
- Being tested
- Local/Regional Public Health Notification
- Keywords
- Influenza infections, Orthomyxoviridae infections, Influenza Human
- 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.
Local/Regional Public Health NotificationBiological
For any H5 positive results, notification of the result to the site's local/regional public health authorities.
| Study group | Role | What they receive |
|---|---|---|
| All | Anyone presenting with influenza-like-illness Receives: Biological: Local/Regional Public Health Notification |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the sensitivity and specificity of influenza A and B, and subtypes A/H1 and A/H3 with nasal and throat specimens for the MSD Influenza test as compared to cell culture and sequencing in a cross-section of the general population
Measured: 4 months
Secondary outcomes (1)
To determine the specificity of influenza subtype A/H5 in nasal and throat specimens for the MSD Influenza test as compared to cell culture and sequencing in a cross section of the general population.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionAug 2010
- Study completionOct 2010
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
- 569 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
- NCT01089816
- Sponsor's protocol ID
- SEA034
- Status last verified
- Apr 2015
- First submitted
- 16 Mar 2010
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. 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 in Asia
- ClinicalTrials.gov ID
- NCT01089816
- Acronym / sponsor ID
- SEA034
- Conditions
- Influenza
- Keywords
- Influenza infections, Orthomyxoviridae infections, Influenza Human
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 569 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
- Aug 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 19 Mar 2010 (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 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: Local/Regional 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 health care facility.
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 to the study, and provides signed authorization for use and disclosure of protected health information.
Key exclusion criteria (3 listed)
- 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.
- Unable to collect nasal and throat swab.
- Severely ill patient without a family relative to provide informed consent.
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 |
|---|---|---|
| Local/Regional Public Health NotificationFor any H5 positive results, notification of the result to the site's local/regional public health authorities. | Biological | All |
Primary outcome
To determine the sensitivity and specificity of influenza A and B, and subtypes A/H1 and A/H3 with nasal and throat specimens for the MSD Influenza test as compared to cell culture and sequencing in a cross-section of the general population
Time frame: 4 months
1 secondary outcome
To determine the specificity of influenza subtype A/H5 in nasal and throat specimens for the MSD Influenza test as compared to cell culture and sequencing in a cross section of the general population.
Time frame: 4 months
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 21 Apr 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.
Jacqueline Perodin, PhD, CCRP study director
Meso Scale Diagnostics
4 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, run by Meso Scale Diagnostics, LLC. at 4 sites in Vietnam.
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 3 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 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Vietnam. 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?
To determine the sensitivity and specificity of influenza A and B, and subtypes A/H1 and A/H3 with nasal and throat specimens for the MSD Influenza test as compared to cell culture and sequencing in a cross-section of the general population (time frame: 4 months). 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 21 Apr 2015; AzTrials last refreshed its copy on 27 Oct 2026.