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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01056354




Registration number
NCT01056354
Ethics application status
Date submitted
25/01/2010
Date registered
26/01/2010
Date last updated
18/08/2017

Titles & IDs
Public title
Respiratory Virus Outpatient Study (FLU 002 Plus)
Scientific title
An International Observational Study to Characterize Adults With Influenza or Other Targeted Respiratory Viruses
Secondary ID [1] 0 0
HHSN261200800001E ; 29XS214
Secondary ID [2] 0 0
0603M83587 FLU 002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza and Other Novel Respiratory Viruses 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Influenza - Influenza A and subtypes such as H3N2 and 2009 H1N1 or influenza B

Novel respiratory virus-1 - MERS-CoV (Middle Eastern Respiratory Syndrome Coronavirus)

Novel respiratory virus-2 - SARS-CoV (Severe Acute Respiratory Syndrome Coronavirus)
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Death or Hospitalization
Timepoint [1] 0 0
14-day period following enrollment
Secondary outcome [1] 0 0
Days of work/school lost, duration of symptoms, use of antivirals
Timepoint [1] 0 0
14 days

Eligibility
Key inclusion criteria
* Be = 18 years of age
* Have a signed informed consent by participant
* Have a fever (37.8 degrees C (100 degrees F) or higher on examination or patient-reported fever (37.8 degrees C (100 degrees F) or higher, or feverishness (felt febrile but did not take temperature) in the past 24 hours.
* Have a cough and/or sore throat
* Have suspected influenza or a suspected targeted non-influenza viral respiratory infection
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Current imprisonment, or compulsory detention (involuntary incarceration) for treatment of a psychiatric or physical illness.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/05/2017
Sample size
Target
Accrual to date
Final
11719
Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC
Recruitment hospital [1] 0 0
Interchange General Practice - Canberra
Recruitment hospital [2] 0 0
Holdsworth House Medical Practice - Darlinghurst
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Prahran Market Clinic - Melbourne
Recruitment hospital [5] 0 0
Northside Clinic - North Fitzroy
Recruitment postcode(s) [1] 0 0
2601 - Canberra
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
3181 - Melbourne
Recruitment postcode(s) [5] 0 0
3068 - North Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Virginia
Country [13] 0 0
Argentina
State/province [13] 0 0
Buenos Aires
Country [14] 0 0
Argentina
State/province [14] 0 0
Santa Fe
Country [15] 0 0
Argentina
State/province [15] 0 0
Cordoba
Country [16] 0 0
Belgium
State/province [16] 0 0
Brussels
Country [17] 0 0
Belgium
State/province [17] 0 0
Tessenderlo
Country [18] 0 0
Chile
State/province [18] 0 0
Santiago
Country [19] 0 0
Denmark
State/province [19] 0 0
Aarhus
Country [20] 0 0
Denmark
State/province [20] 0 0
Copenhagen
Country [21] 0 0
Estonia
State/province [21] 0 0
Tallinn
Country [22] 0 0
Germany
State/province [22] 0 0
Bonn
Country [23] 0 0
Germany
State/province [23] 0 0
Cologne
Country [24] 0 0
Germany
State/province [24] 0 0
Frankfurt
Country [25] 0 0
Germany
State/province [25] 0 0
Hamburg
Country [26] 0 0
Greece
State/province [26] 0 0
Athens
Country [27] 0 0
Japan
State/province [27] 0 0
Nagoya
Country [28] 0 0
Peru
State/province [28] 0 0
Lima
Country [29] 0 0
Poland
State/province [29] 0 0
Warsaw
Country [30] 0 0
Poland
State/province [30] 0 0
Wroclaw
Country [31] 0 0
Spain
State/province [31] 0 0
Valencia
Country [32] 0 0
Spain
State/province [32] 0 0
Vitoria-Gasteiz
Country [33] 0 0
Thailand
State/province [33] 0 0
Bangkok
Country [34] 0 0
Thailand
State/province [34] 0 0
Khon Kaen
Country [35] 0 0
Thailand
State/province [35] 0 0
Nonthaburi
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Norfolk
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Oxford
Country [38] 0 0
United Kingdom
State/province [38] 0 0
West Yorkshire

Funding & Sponsors
Primary sponsor type
Other
Name
University of Minnesota
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute of Allergy and Infectious Diseases (NIAID)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
National Institutes of Health (NIH)
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
James Neaton, Professor
Address 0 0
University of Minnesota - Dept Biostatistics
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01056354