QuickVue Influenza A+B Clinical Field Trial | NCT00491283

Studies
QuickVue Influenza A+B Clinical Field Trial

NCT00491283

Sponsor

Quidel Corporation

Status

Completed

Last Update Posted

Jan 28, 2008Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Influenza

Interventions

Swab Specimen Collection (QuickVue)

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2006

Primary Completion Date

Aug 2006Actual

Completion Date

Aug 2006Actual

First Submitted Date

Jun 22, 2007

First Submission Date that Met QC Criteria

Jun 25, 2007

First Posted Date

Jun 26, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2008

Last Update Posted Date

Jan 28, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Swab Specimen Collection (QuickVue)	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity and Specificity		five months

Secondary Outcomes

Measure	Description	Time Frame
Sensitivity and Specificity		Positive and Negative Predictive Values

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrew Keller, MD	Sydney Airport medical Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sydney Airport Medical Centre		Mascot	New South Wales	2020	Australia

Condition Browse Module

MeSH Terms

ID	Term
D007251	Influenza, Human

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections

Browse Leaves

Not provided

Browse Branches

Not provided