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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00491283




Registration number
NCT00491283
Ethics application status
Date submitted
22/06/2007
Date registered
26/06/2007
Date last updated
28/01/2008

Titles & IDs
Public title
QuickVue Influenza A+B Clinical Field Trial
Scientific title
Comparison of Swab Types for Specimen Collection
Secondary ID [1] 0 0
CS-0119-08(B)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Swab Specimen Collection (QuickVue)

Treatment: Devices: Swab Specimen Collection (QuickVue)


Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sensitivity and Specificity
Timepoint [1] 0 0
five months
Secondary outcome [1] 0 0
Sensitivity and Specificity
Timepoint [1] 0 0
Positive and Negative Predictive Values

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients who are undergoing treatment with antivirals, now or within the last 7 days
cannot be included in this study.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sydney Airport Medical Centre - Mascot
Recruitment postcode(s) [1] 0 0
2020 - Mascot

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Quidel Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A comparative study of different swab types used for collection of specimens for rapid
inluenza testing
Trial website
https://clinicaltrials.gov/show/NCT00491283
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Keller, MD
Address 0 0
Sydney Airport medical Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications