INSIGHT Influenza Outpatient Study (FLU 002)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute Identifier:
First received: January 25, 2010
Last updated: May 30, 2014
Last verified: May 2014

The "flu" is a common disease and usually mild, but severe disease and death may occur. There are several types of flu viruses and they change over time. In 2009 a new influenza A virus, known commonly as swine flu or H1N1v, emerged. This flu virus spread rapidly around the world. However, by November 2010 it became clear in the northern hemisphere that while 2009 pandemic H1N1 virus was still circulating, it was not always the dominant virus in many locations; enrollment of participants was opened to include times when 2009 H1N1 virus was circulating, even if it was not the dominant subtype. Version 3.0 of the protocol (issued June 2011) expanded this further to enrollment of participants with influenza-like illness seeking medical care, regardless of the influenza type in circulation. It is important to understand the course of illness for those who have influenza and the characteristics of people who do not do well. The investigators will also try to learn more about how different treatments and prior vaccination for the flu affects the course of the illness.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An International Observational Study to Characterize Adults With Influenza

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Death or Hospitalization [ Time Frame: 14-day period following enrollment ] [ Designated as safety issue: No ]
    Death or hospitalization within 14 days of enrollment or the development of one severe complication.

Secondary Outcome Measures:
  • Days of work/school lost, duration of symptoms, use of antivirals [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Upper respiratory tract specimen

Serum and plasma

Whole blood for human genomics (only at FLU 002 sites opting to also participate in FLU 004 Genomics and participant has signed an additional consent)

Estimated Enrollment: 5000
Study Start Date: August 2009
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Influenza (Influenza A and subtypes such as H3N2 and 2009 H1N1 or influenza B)

Detailed Description:

The purpose of this observational study is to describe participants in geographically diverse locations with influenza virus infection and their clinical course over a 14-day period following enrollment. Specific objectives are, among patients seeking medical care, to estimate the percentage of patients 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. This information will be used to guide policymakers and to design future studies.

Sample size is open-ended for this observational study. As many participants as possible will be enrolled during each influenza season. Enrollment will continue until the funder and/or protocol team determines that the scientific objectives have been met. Approximately 75 sites in geographically diverse locations across 6 continents, where influenza has been circulating broadly in the community, will enroll participants.

Study Plan:

  • Sites will be opened to enrollment when influenza, of any type, is widely circulating in the community of the participating site.
  • Persons with influenza-like illness will be consecutively enrolled at participating clinical sites.
  • 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 specimen. The respiratory specimen will be sent for central RT-PCR testing for influenza.
  • Status will be re-assessed at approximately 14 days after enrollment and another blood sample for serum and plasma will be obtained.

In February 2012, the FLU 004 Genomics protocol was released to the field. The purpose of this study 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 002 sites are given the option to also participate in FLU 004 which requires a separate protocol registration. Participants, once consented to FLU 002, will be offered the option to also consent to FLU 004 Genomics which includes a single whole blood sample collection. Participation in FLU 002 will not be compromised if a participant opts not to participate in FLU 004 Genomics.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with influenza-like illness, presenting for medical care, will be consecutively enrolled at numerous participating clinical sites across six continents.


Inclusion Criteria:

  • Signed informed consent by patient
  • Age at least 18 years
  • 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.
  • Cough and/or sore throat
  • Suspected influenza

Exclusion Criteria:

  • Current imprisonment, or compulsory detention (involuntary incarceration) for treatment 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: NCT01056354

Contact: James Neaton, Professor 612-626-9040
Contact: Gregg S Larson, Coordinator 612-626-9030

  Show 63 Study Locations
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: James Neaton, Professor University of Minnesota - Dept Biostatistics
  More Information

Additional Information:
Centers for Disease Control and Prevention (CDC). Hospitalized patients with novel influenza A (H1N1) virus infection --- California, April- May, 2009. MMWR 2009 May 18: 58: 1-5.
Centers for Disease Control and Prevention (CDC). Intensive-care patients with severe novel influenza A (H1N1) virus infection---Michigan, June 2009. MMWR 2009 July 10: 58: 1-4.

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Minnesota - Clinical and Translational Science Institute Identifier: NCT01056354     History of Changes
Other Study ID Numbers: 0603M83587 FLU 002, HHSN261200800001E ; 29XS214
Study First Received: January 25, 2010
Last Updated: May 30, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases processed this record on September 18, 2014