Prospective Evaluation of the Fluid Rapid Influenza Test

Nanogen

Status and phase: Suspended; Phase 3

Conditions: Influenza

Treatments: Device: fluID Rapid Influenza Test

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT00826709

FLU-05

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,300 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,300 participants in 3 patient groups

Arm 1

Experimental group

Description:

2 Nasal swabs

Treatment:

Device: fluID Rapid Influenza Test

Arm 2

Experimental group

Description:

2 Nasopharyngeal swabs

Treatment:

Device: fluID Rapid Influenza Test

Arm 3

Experimental group

Description:

Nasal wash or aspirate

Treatment:

Device: fluID Rapid Influenza Test