- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01089816
Rapid Diagnostic Test for Influenza
April 17, 2015 updated by: Meso Scale Diagnostics, LLC.
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
569
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ha Noi, Vietnam
- National Hospital of Pediatrics
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Ho Chi Minh City, Vietnam
- Hospital for Tropical Diseases
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Ho Chi Minh City, Vietnam
- Children's Hospital #2
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Ho Chi Minh City, Vietnam
- Children's Hospital 1
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Individuals visiting a health care facility.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
All
Anyone presenting with influenza-like-illness
|
For any H5 positive results, notification of the result to the site's local/regional public health authorities.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Jacqueline Perodin, PhD, CCRP, Meso Scale Diagnostics
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
October 1, 2010
Study Registration Dates
First Submitted
March 16, 2010
First Submitted That Met QC Criteria
March 18, 2010
First Posted (Estimate)
March 19, 2010
Study Record Updates
Last Update Posted (Estimate)
April 21, 2015
Last Update Submitted That Met QC Criteria
April 17, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SEA034
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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