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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
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)
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.