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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01056185




Registration number
NCT01056185
Ethics application status
Date submitted
25/01/2010
Date registered
26/01/2010
Date last updated
21/10/2024

Titles & IDs
Public title
Respiratory Virus Hospitalization Study (FLU 003 Plus)
Scientific title
An International Observational Study to Characterize Adults Who Are Hospitalized With Influenza or Other Targeted Respiratory Viruses
Secondary ID [1] 0 0
0603M83587 FLU 003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
Novel Respiratory Virus-1 Middle Eastern Respiratory Syndrome Coronavirus (MERS-CoV) 0 0
Novel Respiratory Virus-2 Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV) 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

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 East 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
Timepoint [1] 0 0
60-day period following enrollment
Secondary outcome [1] 0 0
Recovery from influenza illness (including days lost from normal activities) duration of hospitalization, days in intensive care, days of mechanical ventilation, days of dialysis, pregnancy outcome
Timepoint [1] 0 0
approximately 60 days

Eligibility
Key inclusion criteria
* Be = 18 years of age
* Have been admitted to hospital
* Have a signed informed consent by participant or surrogate/representative
* Have a local diagnosis (confirmed or suspected) of influenza, or of a targeted non-influenza viral respiratory infection*, resulting in (or extending a previous) hospitalization

* A list of targeted non-influenza respiratory viruses is maintained on the INSIGHT website.
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 treat 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
30/08/2024
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Darlinghurst
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
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
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
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
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Virginia
Country [13] 0 0
United States of America
State/province [13] 0 0
Wisconsin
Country [14] 0 0
Argentina
State/province [14] 0 0
Buenos Aires
Country [15] 0 0
Argentina
State/province [15] 0 0
Santa Fe
Country [16] 0 0
Argentina
State/province [16] 0 0
Cordoba
Country [17] 0 0
Belgium
State/province [17] 0 0
Brussels
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
Denmark
State/province [21] 0 0
Hvidovre
Country [22] 0 0
Denmark
State/province [22] 0 0
Odense
Country [23] 0 0
Germany
State/province [23] 0 0
Bonn
Country [24] 0 0
Germany
State/province [24] 0 0
Cologne
Country [25] 0 0
Germany
State/province [25] 0 0
Frankfurt
Country [26] 0 0
Greece
State/province [26] 0 0
Athens
Country [27] 0 0
Peru
State/province [27] 0 0
Lima
Country [28] 0 0
Spain
State/province [28] 0 0
Madrid
Country [29] 0 0
Spain
State/province [29] 0 0
Vitoria-Gasteiz
Country [30] 0 0
Thailand
State/province [30] 0 0
Bangkok
Country [31] 0 0
Thailand
State/province [31] 0 0
Khon Kaen
Country [32] 0 0
Thailand
State/province [32] 0 0
Nonthaburi
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Berkshire
Country [34] 0 0
United Kingdom
State/province [34] 0 0
East Sussex
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Oxford
Country [36] 0 0
United Kingdom
State/province [36] 0 0
South Yorkshire
Country [37] 0 0
United Kingdom
State/province [37] 0 0
West Yorkshire
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Newcastle upon Tyne

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
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Clinical & Translational Science Institute, University of Minnesota
Address [3] 0 0
Country [3] 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 estimate rates of morbidity and mortality and to examine predictors of severity among participants with 2009 H1N1 infection. 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. The current version of the protocol (released in August 2013) 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/study/NCT01056185
Trial related presentations / publications
Novel Swine-Origin Influenza A (H1N1) Virus Investigation Team. Emergence of novel swine-origin influenza A (H1N1) virus in humans. N Engl J Med 2009;360:2605-2615.
World Health Organization (WHO), www.who.int/, accessed 26 August 2013
Guery B, Poissy J, el Mansouf L, et al. Clinical features and viral diagnosis of two cases of infection with Middle East Respiratory Syndrome coronavirus: a report of nosocomial transmission. Lancet 2013;381(9885):2265-2272.
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
Wendt CH, Castro-Pearson S, Proper J, Pett S, Griffin TJ, Kan V, Carbone J, Koulouris N, Reilly C, Neaton JD; INSIGHT FLU003 Plus Study Group. Metabolite profiles associated with disease progression in influenza infection. PLoS One. 2021 Apr 2;16(4):e0247493. doi: 10.1371/journal.pone.0247493. eCollection 2021.
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.
Pett SL, Kunisaki KM, Wentworth D, Griffin TJ, Kalomenidis I, Nahra R, Montejano Sanchez R, Hodgson SW, Ruxrungtham K, Dwyer D, Davey RT, Wendt CH; INSIGHT FLU003 Plus Study Group. Increased Indoleamine-2,3-Dioxygenase Activity Is Associated With Poor Clinical Outcome in Adults Hospitalized With Influenza in the INSIGHT FLU003Plus Study. Open Forum Infect Dis. 2017 Oct 25;5(1):ofx228. doi: 10.1093/ofid/ofx228. eCollection 2018 Jan.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Cavan Reilly, PhD
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
Eileen Denning, MPH
Address 0 0
Country 0 0
Phone 0 0
612-626-8049
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01056185