Influenza Diagnosis, Treatment and Surveillance With Xpert Flu

Sponsor

Johns Hopkins University (Other)

Overall Status

Completed

CT.gov ID

NCT01947049

Collaborator

Department of Health and Human Services (U.S. Fed)

2,011

Enrollment

Locations

Arms

Duration (Months)

502.8

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to:

Evaluate the clinical performance of a newly available highly-sensitive rapid influenza test, Xpert Flu.
Derive and validate an adult clinical decision guideline to guide clinical testing of influenza patients who meed CDC criteria for antiviral treatment.
Evaluate impact of rapid influenza testing for antiviral treatment.
Determine cost effectiveness of influenza testing and treatment strategies.

Condition or Disease	Intervention/Treatment	Phase
Influenza	Other: Rapid Influenza Testing with Xpert Flu	N/A

Detailed Description

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

2011 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Influenza Diagnosis, Treatment and Surveillance With Xpert Flu

Study Start Date :

Jul 1, 2013

Actual Primary Completion Date :

Jun 30, 2014

Actual Study Completion Date :

Jun 30, 2014

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Arm Participants in this arm will receive usual care (influenza testing and treatment)
Experimental: Rapid Testing Participants in this arm will receive rapid influenza testing with Xpert Flu.	Other: Rapid Influenza Testing with Xpert Flu Participants with recieve rapid influenza testing with Xpert Flu

Arm

Intervention/Treatment

No Intervention: Control Arm

Participants in this arm will receive usual care (influenza testing and treatment)

Experimental: Rapid Testing

Participants in this arm will receive rapid influenza testing with Xpert Flu.

Other: Rapid Influenza Testing with Xpert Flu

Participants with recieve rapid influenza testing with Xpert Flu

Outcome Measures

Primary Outcome Measures

Clinical performance of Xpert Flu [one year]
The primary outcome is the sensitivity and specificity of Cepheid Xpert Flu in detecting Influenza, as well as the positive and negative predictive value.

Secondary Outcome Measures

Clinical decision guideline [one year]
Using rt-PCR as the gold standard for influenza testing, we will initially evaluate signs and symptoms (such as cough, fever, sore throat, shortness of breath, etc.) for their sensitivity, specificity and likelihood ratio for diagnosing influenza.
Clinical Utility of Xpert Flu [one year]
Clinical utility is defined here as the proportion of high-risk subjects with confirmed influenza receiving antiviral or antiviral prescriptions in the ED in the Rapid Testing Group compared to the Control Group.
Cost-effectiveness [one year]
We will perform a cost-utility analysis from the societal perspective comparing the following 4 treatment strategies: 1) treat all; 2) treat none; 3) treat based on clinical judgment; 4) treat based on Xpert Flu.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18 years old or older
Acute respiratory tract infection, i.e. in the past two days the subject has experienced any of the following symptoms: new or increased cough, new or increased shortness of breath, change in sputum production (for adults 65 years or older), new sinus pain, new nasal congestion/rhinorrhea, new sore throat, new fever, triage temperature greater than or equal to 38F
CDC Criteria for influenza antiviral treatment, i.e. is the subject at risk for influenza complications or does the subject have potential current influenza complications including: 65 years old or older, pregnant (or less than 2 weeks post-partum), American Indian or Alaska Native, morbid obesity (BMI greater than 40), current resident of a chronic care facility, chronic pulmonary disease, cardiovascular disease (except isolated hypertension), renal disease, hepatic disease, hematologic disease, metabolic disease, neurologic disease, immunosupression due to [HIV or AIDS, transplant, chemotherapy, medications, other - specify]. OR does the subject have potential current influenza complications such as: admitted to the hospital or a diagnosis of pneumonia.

Exclusion Criteria:

Unable to speak or understand English or Spanish
Unable to provide consent
Lack of follow up information (i.e. working telephone number)
Have an influenza diagnosis in the past 2 weeks (i.e. either given antivirals or had a confirmatory influenza test)
Previously enrolled in this study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maricopa Medical Center	Phoenix	Arizona	United States	85008
2	Olive View - UCLA Medical Center	Sylmar	California	United States	91342
3	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287
4	Truman Medical Center	Kansas City	Missouri	United States	64108