Rapid Diagnostic Test for Influenza

NCT01089816 | Completed

• 1 other identifier: SEA034
• Study Type: observational
• Target: 569
• Locations: 1 country
• Sites: 4

Brief 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).

Conditions

Influenza

Keywords

Influenza infections; Orthomyxoviridae infections; Influenza Human

Outcome Measures

Primary Outcomes (1)

• 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

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.

  4 months

Study Arms (1)

All

Anyone presenting with influenza-like-illness

Biological: Local/Regional Public Health Notification

Interventions

Local/Regional Public Health Notification BIOLOGICAL

For any H5 positive results, notification of the result to the site's local/regional public health authorities.

All

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals visiting a health care facility.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meso Scale Diagnostics, LLC.: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (4)

National Hospital of Pediatrics

Hà Nội, Vietnam

Location

Children's Hospital #2

Ho Chi Minh City, Vietnam

Location

Children's Hospital 1

Ho Chi Minh City, Vietnam

Location

Hospital for Tropical Diseases

Ho Chi Minh City, Vietnam

Location

Biospecimen

Retention: SAMPLES WITH DNA

Viral transport media containing nasal swab extract.

MeSH Terms

Conditions

Influenza, Human; Orthomyxoviridae Infections

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Jacqueline Perodin, PhD, CCRP

  Meso Scale Diagnostics

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2010
• First Posted: March 19, 2010
• Study Start: March 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: October 1, 2010
• Last Updated: April 21, 2015

Record last verified: 2015-04

Locations

VN (4)