Influenza Diagnosis, Treatment and Surveillance With Xpert Flu

NCT ID: NCT01947049

Last Updated: 2017-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2011 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-06-30

Brief Summary

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.

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).

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Control Arm

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Rapid Testing

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

Group Type: EXPERIMENTAL

Rapid Influenza Testing with Xpert Flu

Intervention Type: OTHER

Participants with recieve rapid influenza testing with Xpert Flu

Interventions

Rapid Influenza Testing with Xpert Flu

Participants with recieve rapid influenza testing with Xpert Flu

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Department of Health and Human Services

FED

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Rich Rothman

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Dugas, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Richard Rothman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Maricopa Medical Center

Phoenix, Arizona, United States

Olive View - UCLA Medical Center

Sylmar, California, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Truman Medical Center

Kansas City, Missouri, United States

Countries

United States

References

Dugas AF, Hsieh YH, LoVecchio F, Moran GJ, Steele MT, Talan DA, Rothman RE; Emergency Department National Influenza Network Investigators. Derivation and Validation of a Clinical Decision Guideline for Influenza Testing in 4 US Emergency Departments. Clin Infect Dis. 2020 Jan 1;70(1):49-58. doi: 10.1093/cid/ciz171.

Reference Type: DERIVED

PMID: 30843056 (View on PubMed)

Other Identifiers

6 IDSEP130014-01-01

Identifier Type: -

Identifier Source: org_study_id