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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)
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Scientific title
An International Observational Study to Characterize Adults With Influenza or Other Targeted Respiratory Viruses
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Secondary ID [1]
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HHSN261200800001E ; 29XS214
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Secondary ID [2]
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0603M83587 FLU 002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Influenza and Other Novel Respiratory Viruses
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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)
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Death or Hospitalization
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Assessment method [1]
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Death or hospitalization within 14 days of enrollment or the development of one severe complication.
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Timepoint [1]
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14-day period following enrollment
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Secondary outcome [1]
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Days of work/school lost, duration of symptoms, use of antivirals
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Assessment method [1]
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Timepoint [1]
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14 days
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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
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Current imprisonment, or compulsory detention (involuntary incarceration) for treatment of a psychiatric or physical illness.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/05/2017
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Sample size
Target
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Accrual to date
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Final
11719
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC
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Recruitment hospital [1]
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Interchange General Practice - Canberra
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Recruitment hospital [2]
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Holdsworth House Medical Practice - Darlinghurst
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Recruitment hospital [3]
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Westmead Hospital - Westmead
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Recruitment hospital [4]
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Prahran Market Clinic - Melbourne
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Recruitment hospital [5]
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Northside Clinic - North Fitzroy
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Recruitment postcode(s) [1]
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2601 - Canberra
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Recruitment postcode(s) [2]
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2010 - Darlinghurst
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Recruitment postcode(s) [3]
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2145 - Westmead
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Recruitment postcode(s) [4]
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3181 - Melbourne
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Recruitment postcode(s) [5]
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3068 - North Fitzroy
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Colorado
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District of Columbia
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Florida
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Illinois
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Michigan
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New Jersey
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New York
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North Carolina
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Tennessee
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Texas
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Virginia
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Argentina
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Buenos Aires
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Argentina
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Santa Fe
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Argentina
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Cordoba
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Belgium
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Brussels
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Belgium
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Tessenderlo
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Chile
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Santiago
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Aarhus
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Copenhagen
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Tallinn
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Germany
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Bonn
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Germany
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Cologne
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Germany
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Frankfurt
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Germany
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Hamburg
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Greece
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Athens
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Japan
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Nagoya
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Peru
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Lima
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Poland
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Warsaw
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Poland
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Wroclaw
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Valencia
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Spain
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Vitoria-Gasteiz
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Thailand
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Bangkok
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Thailand
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Khon Kaen
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Thailand
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Nonthaburi
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United Kingdom
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Norfolk
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United Kingdom
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Oxford
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United Kingdom
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West Yorkshire
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Minnesota
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Government body
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National Institute of Allergy and Infectious Diseases (NIAID)
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National Institutes of Health (NIH)
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Ethics approval
Ethics application status
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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
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Trial website
https://clinicaltrials.gov/study/NCT01056354
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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 Simonsen L, Higgs E, Taylor RJ, Wentworth D, Cozzi-Lepri A, Pett S, Dwyer DE, Davey R, Lynfield R, Losso M, Morales K, Glesby MJ, Weckx J, Carey D, Lane C, Lundgren J; INSIGHT FLU002 and FLU003 Study Groups. Using Clinical Research Networks to Assess Severity of an Emerging Influenza Pandemic. Clin Infect Dis. 2018 Jul 18;67(3):341-349. doi: 10.1093/cid/ciy088. Lynfield R, Davey R, Dwyer DE, Losso MH, Wentworth D, Cozzi-Lepri A, Herman-Lamin K, Cholewinska G, David D, Kuetter S, Ternesgen Z, Uyeki TM, Lane HC, Lundgren J, Neaton JD; INSIGHT Influenza Study Group. Outcomes of influenza A(H1N1)pdm09 virus infection: results from two international cohort studies. PLoS One. 2014 Jul 8;9(7):e101785. doi: 10.1371/journal.pone.0101785. eCollection 2014.
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Public notes
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Contacts
Principal investigator
Name
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James Neaton, Professor
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Address
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University of Minnesota - Dept Biostatistics
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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
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