Influenza Diagnosis, Treatment and Surveillance With Xpert Flu

Completed · Not applicable

Conditions studied: Influenza

In brief

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.

Key facts

Study ID

NCT01947049

Run by

Johns Hopkins University

People needed

2011

Starts

2013-07-01

Expected to finish

2014-06-30

Last updated by the study team

2017-09-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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