Prospective Evaluation of the Fluid Rapid Influenza Test

Paused · Phase 3

Conditions studied: Influenza

In brief

The primary objective of this study is to evaluate the fluID Rapid Influenza Test's ability in detecting influenza A and influenza B from individuals presenting with signs and symptoms of influenza-like illness (ILI).

Key facts

Study ID

NCT00826709

Run by

Nanogen, Inc.

People needed

1300

Starts

2009-02-01

Last updated by the study team

2009-04-15

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. 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 swab samples, nasal wash or aspirate samples is contraindicated or not possible.
• Subjects with a medical condition that prevents swab samples or 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

• Naval Health Research Center — San Diego, California, United States
• University Clinical Research - DeLand, LLC — DeLand, Florida, United States
• Louisiana State University Health Sciences Center — Shreveport, Louisiana, United States
• The Family Doctor Research — Shreveport, Louisiana, United States
• Sinai Grace Hospital — Detroit, Michigan, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• Washington University at St. Louis — St Louis, Missouri, United States
• New York Methodist Hospital — Brooklyn, New York, United States
• Forsyth Medical Center — Winston-Salem, North Carolina, United States
• Granger Medical Clinic — West Valley City, Utah, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• University of Hong Kong — Hong Kong, Hong Kong

Full record on ClinicalTrials.gov

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