INSIGHT Respiratory Virus Hospitalization Study (FLU 003 Plus)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 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: October 9, 2014
Last verified: October 2014
  Purpose

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.


Condition
Influenza
Novel Respiratory Virus-1 MERS-CoV
Novel Respiratory Virus-2 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 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)

  Show Detailed Description

  Eligibility

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.

Criteria

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 ClinicalTrials.gov identifier: NCT01056185

Contacts
Contact: James Neaton, Professor 612-626-9040 neato001@umn.edu
Contact: Kate Brekke, Coordinator 612-626-8615 kahlgren@umn.edu

  Show 63 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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: October 9, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 22, 2014