NCT00828100

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 type B.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
650

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

2 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 23, 2009

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Last Updated

March 6, 2009

Status Verified

March 1, 2009

Enrollment Period

3 months

First QC Date

January 20, 2009

Last Update Submit

March 5, 2009

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

  • Positive percent agreement and negative percent agreement for both influenza A and influenza B.

    End of study

Interventions

fluID Rapid Influenza TestDEVICE

The fluID™ Rapid Influenza Test is an in vitro diagnostic assay designed to be used with a reader for the qualitative detection of influenza type A and type B nucleoprotein antigens, and the differentiation of influenza type A subtypes A/H1 and A/H3 antigens associated with the seasonal influenza H1N1 and H3N2, in nasal swabs, nasopharyngeal swabs and nasal wash/aspirate specimens. The test is intended as an aid in the rapid, qualitative diagnosis of influenza type A and type B viral infections in patients symptomatic with influenza-like illness. The fluID™ Rapid Influenza Test is intended for use by a healthcare professional in a laboratory or Point-of-Care (POC) setting.

BinaxNOW® Influenza A & BDEVICE

The BinaxNOW Influenza A \& B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab and nasal wash/aspirate specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results should be confirmed by culture.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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;
  • 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.

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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Louisiana State University Health Sciences Center

Shreveport, Louisiana, 71103, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 20, 2009

First Posted

January 23, 2009

Study Start

February 1, 2009

Primary Completion

May 1, 2009

Last Updated

March 6, 2009

Record last verified: 2009-03

Locations

US(2)