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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/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
Following the sudden and unexpected emergence of influenza A(H1N1)pdm09 (2009 H1N1) virus,
this observational study was initiated to describe participants seeking medical care in
geographically diverse locations with 2009 H1N1 infection and their clinical course over a
14-day period following enrollment. In 2011, as surveillance indicated that 2009 H1N1 virus
was co-circulating with other seasonal influenza A and B viruses worldwide, the protocol was
expanded to include other influenza A subtypes and influenza B viruses. This version of the
protocol further broadens the scope of this observational study. With the recognition that
novel respiratory viruses other than novel influenza A viruses, e.g., Middle East Respiratory
Syndrome Coronavirus (MERS-CoV), could become prevalent and of major public health
importance, the objectives of this protocol have been expanded
Trial website
https://clinicaltrials.gov/ct2/show/NCT01056354
Trial related presentations / publications
Novel Swine-Origin Influenza A (H1N1) Virus Investigation Team; Dawood FS, Jain S, Finelli L, Shaw MW, Lindstrom S, Garten RJ, Gubareva LV, Xu X, Bridges CB, Uyeki TM. Emergence of a novel swine-origin influenza A (H1N1) virus in humans. N Engl J Med. 2009 Jun 18;360(25):2605-15. doi: 10.1056/NEJMoa0903810. Epub 2009 May 7. Erratum In: N Engl J Med. 2009 Jul 2;361(1):102.
World Health Organization (WHO), www.who.int/, accessed 26 August 2013
Guery B, Poissy J, el Mansouf L, Sejourne C, Ettahar N, Lemaire X, Vuotto F, Goffard A, Behillil S, Enouf V, Caro V, Mailles A, Che D, Manuguerra JC, Mathieu D, Fontanet A, van der Werf S; MERS-CoV study group. Clinical features and viral diagnosis of two cases of infection with Middle East Respiratory Syndrome coronavirus: a report of nosocomial transmission. Lancet. 2013 Jun 29;381(9885):2265-72. doi: 10.1016/S0140-6736(13)60982-4. Epub 2013 May 30. Erratum In: Lancet. 2013 Jun 29;381(9885):2254.
Drosten C, Seilmaier M, Corman VM, Hartmann W, Scheible G, Sack S, Guggemos W, Kallies R, Muth D, Junglen S, Muller MA, Haas W, Guberina H, Rohnisch T, Schmid-Wendtner M, Aldabbagh S, Dittmer U, Gold H, Graf P, Bonin F, Rambaut A, Wendtner CM. Clinical features and virological analysis of a case of Middle East respiratory syndrome coronavirus infection. Lancet Infect Dis. 2013 Sep;13(9):745-51. doi: 10.1016/S1473-3099(13)70154-3. Epub 2013 Jun 17.
World Health Organization (WHO), Severe Acute Respiratory Syndrome (SARS), www.who.int/csr/sars/, accessed 26 August 2013
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01056354