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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Sex
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
1/07/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2006
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00491283