NCT00491283

Brief Summary

A comparative study of different swab types used for collection of specimens for rapid inluenza testing

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jul 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

July 1, 2006

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2007

Completed
Last Updated

January 28, 2008

Status Verified

January 1, 2008

Enrollment Period

1 month

First QC Date

June 22, 2007

Last Update Submit

January 23, 2008

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and Specificity

    five months

Secondary Outcomes (1)

  • Sensitivity and Specificity

    Positive and Negative Predictive Values

Interventions

Swab Specimen Collection (QuickVue)DEVICE

Eligibility Criteria

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

You may qualify if:

  • Subjects must have:
  • Fever (\>38°C) (at time of visit or within the previous 48 hrs by history) and at least two of the following symptoms:
  • Chills/sweats
  • Cough
  • Dyspnea (labored, difficult breathing)
  • Fatigue
  • Headache
  • Myalgia (deep muscle aches)
  • Nasal congestion
  • Runny nose
  • Sore throat

You may not qualify if:

  • Patients who are undergoing treatment with antivirals, now or within the last 7 days cannot be included in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sydney Airport Medical Centre

Mascot, New South Wales, 2020, Australia

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Andrew Keller, MD

    Sydney Airport medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 22, 2007

First Posted

June 26, 2007

Study Start

July 1, 2006

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

January 28, 2008

Record last verified: 2008-01

Locations

AU(1)