Clinical trial NCT00826709: Prospective Evaluation of the Fluid Rapid Influenza Test
Official title: CLINICAL STUDY PROTOCOL for the Prospective Evaluation of the fluID Rapid Influenza Test
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Influenza
Lead sponsor: Nanogen, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2009-01-22
Enrollment: 1300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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-like illness (ILI).

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 fresh samples collected prospectively from individuals presenting with signs and symptoms of influenza-like illness (ILI). Test results will be compared with those obtained from viral culture testing of samples using the same specimen types, obtained from the same subjects. The specimen types under evaluation in this study will be nasal swab, nasopharyngeal swab, nasal wash and aspirate specimens.

A secondary objective of this study is to evaluate the accuracy of the fluID Rapid Influenza Test in detecting each of the H1 and H3 subtypes of influenza A, in nasal swab, nasopharyngeal swab, nasal wash and aspirate specimens.

Eligibility criteria: Inclusion Criteria:

1. Male or female subjects of any age;
2. 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;
3. 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 Criteria:

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

Primary outcomes:
measure: Sensitivity and specificity of influenza A and influenza B
timeFrame: End of study
Secondary outcomes:
measure: Sensitivity and specificity of influenza A subtypes H1N1 and H3N2
timeFrame: End of study
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Health Research Center
state: California
city: DeLand
country: United States
facility: University Clinical Research - DeLand, LLC
state: Florida
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Center
state: Louisiana
city: Shreveport
country: United States
facility: The Family Doctor Research
state: Louisiana
city: Detroit
country: United States
facility: Sinai Grace Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: St. Louis
country: United States
facility: Washington University at St. Louis
state: Missouri
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: West Valley City
country: United States
facility: Granger Medical Clinic
state: Utah
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Hong Kong
country: Hong Kong
facility: University of Hong Kong
Study officials:
References: