Status:
SUSPENDED
Prospective Evaluation of the Fluid Rapid Influenza Test
Lead Sponsor:
Nanogen, Inc.
Collaborating Sponsors:
Centers for Disease Control and Prevention
Conditions:
Influenza
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
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-li...
Detailed Description
The primary objective of this study is to evaluate the clinical sensitivity and specificity of the fluID Rapid Influenza Test in detecting influenza A and influenza B, as evaluated with respect to fre...
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. 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 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
1300 Patients enrolled
Trial Details
Trial ID
NCT00826709
Start Date
February 1 2009
Last Update
April 15 2009
Active Locations (13)
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1
Naval Health Research Center
San Diego, California, United States, 92152
2
University Clinical Research - DeLand, LLC
DeLand, Florida, United States, 32720
3
Louisiana State University Health Sciences Center
Shreveport, Louisiana, United States, 71103
4
The Family Doctor Research
Shreveport, Louisiana, United States, 71115