Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1000 participants
OBSERVATIONAL
2009-08-31
2024-08-30
Brief Summary
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Detailed Description
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Specific objectives related to influenza virus infection are to estimate the percentage of participants who go on to develop severe disease or complications that require hospitalization; to obtain information on risk factors for disease severity; and to establish a central repository of specimens for use in virus characterization, including subtyping, antigenic and genetic analyses, identification of signature mutations associated with antiviral drug resistance, mutational evolution, and additional reassortment.
Specific objectives related to novel non-influenza respiratory viruses of potential major public health importance are to characterize initial cases and their outcomes in order to develop more specific protocols that could inform the prevention and treatment of these new infections.
The information used from this study on participants with influenza and novel respiratory virus infections will be rapidly analyzed and shared broadly in order to guide policymakers and to design future studies.
Approximately 500 patients with influenza will be enrolled each year at an estimated 75 sites which are in geographically diverse locations across several continents.
Study Plan:
* Participants who meet the eligibility criteria will be enrolled at participating clinical sites.
* Patients with a diagnosis of influenza (confirmed or suspected), who are hospitalized with complications or severe disease, will be enrolled.
* At enrollment, consent is signed and information (demographics, medical history (including prior influenza and pneumococcal vaccination), medications (including antivirals) and treatments prescribed) will be recorded. A blood sample for serum and plasma will be obtained at enrollment, as well as an upper respiratory tract sample and lower respiratory tract sample, if appropriate. The respiratory specimens will be sent for central reverse transcriptase polymerase chain reaction (RT-PCR) testing for influenza.
* For participants who are still hospitalized, and not intubated, 5 to 7 days after enrollment an additional upper respiratory sample is obtained.
* Status will be re-assessed at approximately 28 days and 60 days after enrollment and another blood sample for serum and plasma will obtained at both time points.
* For participants who are mechanically ventilated additional upper and lower respiratory tract specimens will be obtained at specific timepoints.
In February 2012, the FLU 004 Genomics protocol v 1.0 was released to the field. In August 2013, v 2.0 of the protocol was released as INSIGHT Genomics. The protocol was expanded beyond the FLU 002 and FLU 003 studies to include all qualifying INSIGHT studies (list of qualifying studies is posted on the INSIGHT website, www.insight-trials.org). The purpose of this substudy is to obtain a whole blood sample from which DNA will be extracted to study polymorphisms in immune response genes and other genetic variants that may be associated with an increased risk of severe influenza.
Participating FLU 003 Plus sites are given the option to also participate in INSIGHT Genomics which requires a separate protocol registration. Participants, once consented to FLU 003 Plus, will be offered the option to also consent to INSIGHT Genomics which includes a single whole blood sample collection. Participation in FLU 003 Plus will not be compromised if a participant opts not to participate in INSIGHT Genomics.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Influenza
Influenza A and subtypes such as H3N2 and 2009 H1N1 or influenza B
No interventions assigned to this group
Novel Respiratory Virus-1
MERS-CoV (Middle East Respiratory Syndrome Coronavirus
No interventions assigned to this group
Novel Respiratory Virus-2
SARS-CoV (Severe Acute Respiratory Syndrome Coronavirus)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
National Institutes of Health (NIH)
NIH
Clinical & Translational Science Institute, University of Minnesota
UNKNOWN
University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Cavan Reilly, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota - Dept Biostatistics
Locations
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UCSD Antiviral Research Center
San Diego, California, United States
George Washington Medical Faculty Associates
Washington D.C., District of Columbia, United States
Washington DC VA Medical Center
Washington D.C., District of Columbia, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Baystate Infectious Diseases Clinical Research
Springfield, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Cooper University Hospital
Camden, New Jersey, United States
New Jersey Medical School Adult Clinical Research Center
Newark, New Jersey, United States
Cornell ID-CRU
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke University
Durham, North Carolina, United States
The Ohio State University Medical Center
Columbus, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
University of Tennessee College of Medicine
Chattanooga, Tennessee, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Hospital Nacional Profesor Alejandro Posadas
El Palomar, Buenos Aires, Argentina
Instituto Medico Platense
La Plata, Buenos Aires, Argentina
Hospital Universitario Austral
Pilar, Buenos Aires, Argentina
Hospital Profesor Bernardo Houssay
Vicente López, Buenos Aires, Argentina
Sanatorio Britanico
Rosario, Santa Fe Province, Argentina
CEMIC
Buenos Aires, , Argentina
Hospital General de Agudos JM Ramos Mejia
Buenos Aires, , Argentina
Hospital Interzonal General de Agudos Dr. Diego Paroissien
Buenos Aires, , Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, , Argentina
Hospital Privado Centro Medico de Cordoba
Córdoba, , Argentina
Hospital Rawson
Córdoba, , Argentina
St. Vincent's Hospital
Darlinghurst, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Centre Hospitalier Universitaire St. Pierre (C.H.U. St. Pierre)
Brussels, , Belgium
Clinica Alemana
Santiago, , Chile
Fundacion Arriaran
Santiago, , Chile
Arhus Universitetshospital, Skejby
Aarhus, , Denmark
CHIP
Copenhagen, , Denmark
Hvidovre University Hospital, Department of Infectious Diseases
Hvidovre, , Denmark
Odense University Hospital
Odense, , Denmark
Medizinische Universitatsklinik - Bonn, Immunologische Ambulanz CRS
Bonn, , Germany
Klinik I fur Innere Medizin der Universitat zu Koln, Studienburo fur Infektiologie u. HIV
Cologne, , Germany
Johann Wolfgang Goethe - University Hospital, Infektionsambulanz CRS
Frankfurt, , Germany
1st Dept of Critical Care Medicine and Pulmonary Services, Evangelismos Hospital
Athens, , Greece
1st Respiratory Medicine Dept, Athens Hosp for Diseases of the Chest "Sotiria Hospital"
Athens, , Greece
Evangelismos General Hospital
Athens, , Greece
Hippokration University General Hospital of Athens
Athens, , Greece
Hospital Nacional Arzobispo Loayza
Lima, , Peru
Hospital Nacional Guillermo Almenara Irigoyen
Lima, , Peru
Hospital Clinico San Carlos
Madrid, , Spain
Hospital La Paz
Madrid, , Spain
Hospital Universitario Gregorio Mara�on
Madrid, , Spain
Hospital Universitario Infanta Leonor
Madrid, , Spain
Hospital Txagorritxu
Vitoria-Gasteiz, , Spain
Chulalongkorn University Hospital
Bangkok, , Thailand
Khon Kaen University, Srinagarind Hospital
Khon Kaen, , Thailand
Bamrasnaradura Institute
Nonthaburi, , Thailand
Heatherwood and Wexham Park Hospitals NHS Foundation Trust
Slough, Berkshire, United Kingdom
Brighton and Sussex University Hospitals NHS Trust
Brighton, East Sussex, United Kingdom
Churchill Hospital
Headington, Oxford, United Kingdom
Sheffield Teaching Hospital NHS Foundation Trust
Sheffield, South Yorkshire, United Kingdom
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, West Yorkshire, United Kingdom
St James's University Hospital
Leeds, West Yorkshire, United Kingdom
Newcastle General Hospital
Newcastle upon Tyne, , United Kingdom
Countries
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References
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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.
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.
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.
Related Links
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INSIGHT website
Other Identifiers
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0603M83587 FLU 003
Identifier Type: -
Identifier Source: org_study_id
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