Status:
SUSPENDED
Comparison of Fluid Rapid Influenza and BinaxNOW Influenza A & B
Lead Sponsor:
Nanogen, Inc.
Conditions:
Influenza
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT00828100
Start Date
February 1 2009
Last Update
March 6 2009
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Louisiana State University Health Sciences Center
Shreveport, Louisiana, United States, 71103
2
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226