Rapid Diagnostic Test for Influenza

Influenza Clinical Trial

Official title:

Clinical Validation of the Point-of-Care MSD Influenza Test in Asia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01089816
• Other study ID #: SEA034
• Status: Completed
• Phase: N/A
• First received: March 16, 2010
• Last updated: April 17, 2015
• Start date: March 2010
• Est. completion date: October 2010

Study information

• Verified date: April 2015
• Source: Meso Scale Diagnostics, LLC.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Ministry of HealthUnited States: Food and Drug Administration
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Local/Regional Public Health Notification
For any H5 positive results, notification of the result to the site's local/regional public health authorities.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Meso Scale Diagnostics, LLC.	Centers for Disease Control and Prevention

Country where clinical trial is conducted

Vietnam, 

Outcome

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