INSIGHT Influenza Hospitalization Study (FLU 003)

This study is currently recruiting participants.
Verified September 2013 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Collaborators:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01056185
First received: January 25, 2010
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

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 2.0 of the protocol (issued June 2011) expanded this further to enrollment of participants with confirmed or suspected influenza of any type. 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. The results of this study will be used to advise on the management of patients who are hospitalized with the flu.


Condition
Influenza
(Influenza A and Subtypes Such as H3N2 and 2009 H1N1 or Influenza B)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An International Observational Study to Characterize Adults Who Are Hospitalized With Complications of Influenza

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: 60 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum, plasma, respiratory

Whole blood for human genomics (only for FLU 003 sites opting to also participate in FLU 004 Genomics and participant has signed an additional consent)


Estimated Enrollment: 1000
Study Start Date: August 2009
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Detailed Description:

The purpose of this observational study is to describe the characteristics and outcomes over a 60-day follow-up period of participants with influenza virus infection (including influenza A subtypes such as H3N2 and 2009 H1N1, or influenza B) who are hospitalized with severe illness and/or complications in geographically diverse locations. Specific objectives are to determine the percentage of patients who die or develop other adverse outcomes following hospitalization for complications associated with influenza, to obtain information on risk factors for mortality and other adverse outcomes, 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:

  • Participating clinical sites will be opened to enrollment when influenza, of any type, is widely circulating in the community.
  • 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 specimen. The respiratory specimens will be sent for central 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 time points.

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 003 sites are given the option to also participate in FLU 004 which requires a separate protocol registration. Participants, once consented to FLU 003, will be offered the option to also consent to FLU 004 Genomics which includes a single whole blood sample collection. Participation in FLU 003 will not be compromised if a participant opts not to participate in FLU 004 Genomics.

  Eligibility

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 a diagnosis of influenza (confirmed or suspected)of any type, who are hospitalized with complications or severe disease, will be enrolled. Patients 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 was made. Enrollment will occur at more than 70 participating clinical sites across 6 continents.

Criteria

Inclusion Criteria:

  • Signed informed consent by participant or surrogate/representative
  • Local diagnosis of influenza(confirmed or suspect)
  • Age at least 18 years
  • Hospitalized for severe and/or complicated influenza defined as one or more of the following:
  • Respiratory distress requiring supplemental oxygen
  • Exacerbation of a pre-existing medical condition
  • Circulatory collapse defined as requirement for vasopressor support despite adequate hydration
  • Acute renal dysfunction or failure
  • Acute liver dysfunction or failure
  • Pregnancy-related complications, e.g., premature labor
  • Other severe organ dysfunction, e.g., encephalitis, meningitis, peripheral neurological disease, myocarditis, enteritis, myositis, or invasive bacterial infection

Exclusion Criteria:

  • Current imprisonment, or compulsory detention (involuntary incarceration) for treat of a psychiatric or physical illness.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01056185

Contacts
Contact: James Neaton, Professor 612-626-9040 neato001@umn.edu
Contact: Gregg S Larson, Coordinator 612-626-9030 larso279@umn.edu

  Show 71 Study Locations
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: James Neaton, Professor University of Minnesota - Dept Biostatistics
  More Information

Additional Information:
Publications:
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.
Iwasenko JM, Cretikos M, Paterson DL, et al. Enhanced diagnosis of pandemic (H1N1) 2009 influenza infection using molecular and serological testing in intensive care patients with suspected influenza. Clinical Infectious Diseases 2010: 51:70-72

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01056185     History of Changes
Other Study ID Numbers: 0603M83587 FLU 003
Study First Received: January 25, 2010
Last Updated: September 3, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 15, 2014