Influenza Clinical Trial
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).
Status | Completed |
Enrollment | 569 |
Est. completion date | October 2010 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Vietnam | National Hospital of Pediatrics | Ha Noi | |
Vietnam | Children's Hospital #2 | Ho Chi Minh City | |
Vietnam | Children's Hospital 1 | Ho Chi Minh City | |
Vietnam | Hospital for Tropical Diseases | Ho Chi Minh City |
Lead Sponsor | Collaborator |
---|---|
Meso Scale Diagnostics, LLC. | Centers for Disease Control and Prevention |
Vietnam,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 4 months | No | |
Secondary | 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. | 4 months | No |
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