Comparison of Fluid Rapid Influenza and BinaxNOW Influenza A & B

Paused · Phase 3

Conditions studied: Influenza

In brief

The primary objective of this study is to compare the performance of the investigational fluid Rapid Influenza Test and the BinaxNOW® Influenza A \& B Test in detecting influenza type A and influenza type B.

Key facts

Study ID

NCT00828100

Run by

Nanogen, Inc.

People needed

650

Starts

2009-02-01

Last updated by the study team

2009-03-06

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects of any age;
• Subjects presenting to the investigative site within 4 days of symptom onset, with:
• Fever ≥ 38.0°C (100.4°F) if taken orally, or ≥ 38.5°C (101.2°F) if taken rectally; or a self-reported history of fever or feeling feverish (includes fever controlled by medication) in the absence of documented fever;
• One or more respiratory symptoms of influenza-like illness which may include the following:
• Sore throat
• Runny or stuffy nose
• Cough
• One or more constitutional symptoms of influenza-like illness which may include the following:
• Myalgia (aches and pains)
• Headache
• Fatigue
• Subjects (or parent/guardian) willing and able to provide informed consent;
• Subjects must be enrolled in Arm 3 of the FLU-05 clinical study.
• Written subject informed consent for this study protocol must be obtained prior to study enrollment. Each subject (or parent or guardian) must personally sign and date the Subject Informed Consent Form prior to his/her participation in this clinical study.

You may not qualify if…

• Subjects not presenting with at least three symptoms of influenza-like illness as outlined above.
• Subjects who have received influenza antiviral medication or an investigational influenza drug treatment within the previous 30 days of study enrollment.
• Subjects (children and adults) for whom the obtaining of aspirate samples is contraindicated or not possible.
• Subjects with a medical condition that prevents nasal washes or aspirate samples from being obtained.
• Active duty military personnel (participating military study sites only).
• Subjects (or parent/guardian) unwilling or unable to provide informed consent.

Where it is running

• Louisiana State University Health Sciences Center — Shreveport, Louisiana, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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