Influenza Clinical Trial
Official title:
Influenza Diagnosis, Treatment and Surveillance With Xpert Flu
The purpose of this study is to:
1. Evaluate the clinical performance of a newly available highly-sensitive rapid influenza
test, Xpert Flu.
2. Derive and validate an adult clinical decision guideline to guide clinical testing of
influenza patients who meed CDC criteria for antiviral treatment.
3. Evaluate impact of rapid influenza testing for antiviral treatment.
4. Determine cost effectiveness of influenza testing and treatment strategies.
Four strategically selected medical centers across the US (representing the West Coast,
Southwest, Midwest; and East Coast) will enroll adult subjects presenting to the ED with an
acute respiratory illness who fulfill CDC recommended criteria for receiving antiviral
therapy. At each of the 4 sites, dedicated research coordinators will approach all adult (age
> 18 years old) ED patients with broadly defined respiratory related complaints and screen
for those who meet CDC recommended criteria for antiviral therapy (i.e. those at 'high-risk
for complications' or those with 'potential influenza-related complications).
Consenting subjects will have a nasopharyngeal (NP) swab collected for both Xpert Flu testing
and gold standard reverse transcription-PCR (rt-PCR) testing under a research protocol. The
investigators will compare the test results from the rapid flu testing to that of the gold
standard rt-PCR testing in order to assess the clinical performance characteristics of the
new rapid test (Objective 1). The investigators will also collect demographics and medical
historical information using a brief structured data form, which will be used in combination
with rt-PCR test results to derive and validate a clinical decision guideline (Objective 2).
The investigators will simultaneously randomize 2 of the 4 hospitals to the Rapid Testing
Group (which will have systematic rapid flu testing performed with results provided to the
clinicians), or the Control Group (which will follow standard of care practice with testing
left to the discretion of individual clinicians). This will permit comparison of rates of ED
antiviral administration or prescription between the two groups to assess the clinical impact
of influenza testing (Objective 3). Finally, cost data from the ED visits and subsequent
hospitalization will be collected from subjects in both the rapid testing group and the
control group to inform a cost-utility analysis of rapid influenza testing compared to
current standard of care (Objective 4).
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