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INSIGHT Respiratory Virus Outpatient Study (FLU 002 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:
NCT01056354
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 describe participants seeking medical care in geographically diverse locations with 2009 H1N1 infection and their clinical course over a 14-day period following enrollment. 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. This version of the protocol 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 and Other Novel Respiratory Viruses

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

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 at FLU 002 Plus sites opting to also participate in INSIGHT 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)
Groups/Cohorts
Influenza
Influenza A and subtypes such as H3N2 and 2009 H1N1 or influenza B
Novel respiratory virus-1
MERS-CoV (Middle Eastern Respiratory Syndrome Coronavirus)
Novel respiratory virus-2
SARS-CoV (Severe Acute Respiratory Syndrome Coronavirus)

Detailed Description:

The purpose of this observational study is to describe participants in geographically diverse locations with influenza virus infection and other viral respiratory diseases of public health importance and their clinical course over a 14-day period following enrollment.

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

Sample size is open-ended for this observational study. Based on experience to date, it is estimated that 75 sites will participate and will enroll approximately 1,700 patients with influenza each year, about one-half in the Northern Hemisphere and one-half in the Southern Hemisphere. Sites in diverse geographic locations on several continents will participate.

Study Plan:

  • Participants who meet the eligibility criteria will be 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. For participants with a confirmed novel respiratory virus of public health importance, attempts will be made to obtain a sample of the local specimen used to diagnose the infection.

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 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 disease progression among individuals with infectious diseases of public health importance who are enrolled in qualifying INSIGHT studies.

Participating FLU 002 Plus sites are given the option to also participate in INSIGHT Genomics, which requires a separate protocol registration. Participants, once consented to FLU 002 Plus, will be offered the option to also consent to INSIGHT Genomics, which includes a single whole blood sample collection. Participation in FLU 002 Plus will not be compromised if a participant opts not to participate in INSIGHT 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

Persons who seek medical care and are suspected of having influenza or a targeted novel respiratory virus* of major public health concern will be enrolled at numerous participating clinical sites on several continents.

*The current list of other targeted novel respiratory viruses includes MERS-CoV and SARS-CoV.

Criteria

Inclusion Criteria:

  • Be ≥ 18 years of age
  • Have a signed informed consent by participant
  • Have a 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.
  • Have a cough and/or sore throat
  • Have suspected influenza or a suspected targeted non-influenza viral respiratory infection

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 ClinicalTrials.gov identifier: NCT01056354

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

  Show 67 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: NCT01056354     History of Changes
Other Study ID Numbers: 0603M83587 FLU 002, HHSN261200800001E ; 29XS214
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
respiratory virus
pandemic
swine flu
infection
MERS-CoV
SARS-CoV

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

ClinicalTrials.gov processed this record on November 24, 2014