FLU A+B Nasal Swab Clinical Study
FLUA+B
Evaluation of the RAMP FLU A+B Test Versus Viral Culture Using Clinical Nasal Swab Samples From Patients With Suspected Influenza Infections
1 other identifier
observational
800
2 countries
5
Brief Summary
The purpose of this clinical study is to obtain clearance for the nasal swab sample type by demonstrating the performance characteristics of the FLU A+B Test versus standard laboratory culture for Influenza A and B viruses using nasal swab samples.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2008
Shorter than P25 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 7, 2008
CompletedFirst Posted
Study publicly available on registry
March 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedMarch 27, 2019
March 1, 2019
3 months
March 7, 2008
March 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Support the addition of nasal swab sample type to labeling for the FLU A+B Test. The nasal swab sample data will be analyzed for the FLU A+B Test versus standard laboratory culture identification to determine the sensitivity and specificity.
1 day
Study Arms (1)
all
any patient exhibiting symptoms of influenza
Interventions
Eligibility Criteria
Nasal swab samples will be collected from subjects suspected of having influenza infections and onset has occurred within 3 days of examination. Across the sites these samples will be drawn from an approximately 60% pediatric patients (\<21 years), and 40% adult patients (\>21 years) and it is expected that the population will be divided approximately equally between males and females.
You may qualify if:
- Male and Female of all age groups
- Patients exhibiting influenza symptoms (i.e., fever, body aches, headaches, cough, sore throat, and other respiratory symptoms) at the time of examination
- Patients must either present with a fever (\>100ºF; \>37.8ºC) at time of examination or have had a fever (\>100ºF; \>37.8ºC) or declare at time of the examination that they had a fever within the previous 3 days prior to the examination
- Must be able to collect sample using the nasal swab sample type
You may not qualify if:
- Patients with no fever at time of examination or within the 3 days prior to examination and/or are currently undergoing treatment (including anti-virals) will be excluded from the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Northwestern University
Chicago, Illinois, United States
Washington University / St. Louis Children's Hospital
St Louis, Missouri, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Dell Children's Hospital
Austin, Texas, United States
Mt. Sinai Hospital
Toronto, Ontario, Canada
Biospecimen
mucous
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2008
First Posted
March 14, 2008
Study Start
February 1, 2008
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
March 27, 2019
Record last verified: 2019-03