NCT03417869

Brief Summary

Demonstrate improved clinical performance of visually read QuickVue Influenza A+B test.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,381

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

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

Study Start

First participant enrolled

February 16, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

March 20, 2018

Status Verified

March 1, 2018

Enrollment Period

12 months

First QC Date

January 24, 2018

Last Update Submit

March 16, 2018

Conditions

Influenza A, Influenza B

Outcome Measures

Primary Outcomes (1)

  • Influenza Diagnostic test result

    rapid IVD test

    10 minutes

Interventions

QuickVue Influenza A+BDEVICE

Rapid diagnostic test with IVD, QuickVue Influenza A+B

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects will be recruited from the general population as they present to the clinical facility. Subjects must have had a fever within the last two days and exhibiting one or more symptoms characteristic of influenza

You may qualify if:

  • Subjects will be recruited from the general population as they present to the clinical facility. Subjects must have had a fever within the last two days and exhibiting one or more symptoms characteristic of influenza. They must meet the following criteria to be eligible for enrollment:
  • Male or Female of all ages (with appropriate consent).
  • The subject must have had of a fever, ≥ 37.8º C (100º F), within the last two days.
  • Must also be currently exhibiting one or more of the following symptoms characteristic of influenza-like-illness (ILI).
  • Nasal congestion
  • Rhinorrhea
  • Sore throat
  • Cough
  • Headache
  • Myalgia
  • Malaise

You may not qualify if:

  • \. Has undergone treatment with anti-influenza antivirals within the previous 7 days, to include but not be limited to, Amantadine, Rimantadine, Ribavirin, Oseltamivir, Zanamivir or any other antiviral currently available in these classes.
  • \. Has been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days.
  • \. Unable to understand and consent to participation; for minors this includes parent or legal guardian.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Alliance Urgent Care

Phoenix, Arizona, 85353, United States

Location

Twelve Corners Pediatrics

Rochester, New York, 14618, United States

Location

Veritas, P.A.

Belton, Texas, 76513, United States

Location

City Doc Urgent Care

Dallas, Texas, 75209, United States

Location

Advanced Pediatrics

Vienna, Virginia, 22180, United States

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2018

First Posted

January 31, 2018

Study Start

February 16, 2017

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

March 20, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

US(5)