Respiratory Virus Hospitalization Study (FLU 003 Plus)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by University of Minnesota - Clinical and Translational Science Institute
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute Identifier:
First received: January 25, 2010
Last updated: November 30, 2015
Last verified: November 2015
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.

Novel Respiratory Virus-1 Middle Eastern Respiratory Syndrome Coronavirus (MERS-CoV)
Novel Respiratory Virus-2 Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An International Observational Study to Characterize Adults Who Are Hospitalized With Influenza or Other Targeted Respiratory Viruses

Resource links provided by NLM:

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Death [ Time Frame: 60-day period following enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: approximately 60 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum, plasma, respiratory for all participants. For participants with a confirmed targeted non-influenza respiratory virus, attempts will be made to obtain a sample of the local specimen used to confirm diagnosis.

Whole blood for human genomics (only for FLU 003 Plus sites opting to also participate in INSIGHT Genomics and participant has signed an additional consent)

Estimated Enrollment: 1000
Study Start Date: August 2009
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
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)

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Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients who are hospitalized with a diagnosis (confirmed or suspected) of influenza or a targeted non-influenza viral respiratory infection, as soon as possible after the suspected diagnosis is made. Participants may have already been admitted to the hospital at the study site or may have been previously seen at another hospital where the diagnosis of influenza or infection with a targeted respiratory virus was made.

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.

Exclusion Criteria:

  • Current imprisonment, or compulsory detention (involuntary incarceration) for treat of a psychiatric or physical illness.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01056185

Contact: James Neaton, Professor 612-626-9040
Contact: Kate Brekke, Coordinator 612-626-8615

  Show 63 Study Locations
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
Principal Investigator: James Neaton, Professor University of Minnesota - Dept Biostatistics
  More Information

Additional Information:
World Health Organization (WHO),, accessed 26 August 2013
World Health Organization (WHO), Severe Acute Respiratory Syndrome (SARS),, accessed 26 August 2013

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Minnesota - Clinical and Translational Science Institute Identifier: NCT01056185     History of Changes
Other Study ID Numbers: 0603M83587 FLU 003 
Study First Received: January 25, 2010
Last Updated: November 30, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
swine flu
respiratory virus

Additional relevant MeSH terms:
Influenza, Human
Coronavirus Infections
Severe Acute Respiratory Syndrome
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
Orthomyxoviridae Infections
Pathologic Processes
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections processed this record on May 25, 2016