Respiratory Virus Hospitalization Study (FLU 003 Plus)



Status:Recruiting
Conditions:Influenza, Infectious Disease, Pulmonary
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:1/26/2019
Start Date:August 2009
End Date:December 2019
Contact:James Neaton, Professor
Email:neato001@umn.edu
Phone:612-626-9040

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An International Observational Study to Characterize Adults Who Are Hospitalized With Influenza or Other Targeted Respiratory Viruses

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.

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), or a targeted non-influenza
respiratory virus, who are hospitalized with severe illness and/or complications in
geographically diverse locations.

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.

The information used from this study on participants with influenza and novel respiratory
virus infections will be rapidly analyzed and shared broadly in order to guide policymakers
and to design future studies.

Approximately 500 patients with influenza will be enrolled each year at an estimated 75 sites
which are in geographically diverse locations across several continents.

Study Plan:

- Participants who meet the eligibility criteria will be enrolled at participating
clinical sites.

- 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 sample and
lower respiratory tract sample, if appropriate. The respiratory specimens will be sent
for central reverse transcriptase polymerase chain reaction (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 timepoints.

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 of
qualifying studies is 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 severe influenza.

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

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.
We found this trial at
19
sites
New York, New York 10011
Principal Investigator: Roy Gulick, MD
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Namrata Patil, MD, MPH
Phone: 617-732-8042
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Paul Riska, M.D.
Phone: 718-920-6494
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Cameron Wolfe
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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1 Cooper Plaza
Camden, New Jersey 08103
(856) 342-2000
Principal Investigator: Raquel Nahra, MD
Phone: 856-757-7843
Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
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Camden, NJ
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Chattanooga, Tennessee 37403
Principal Investigator: John Gunter, MD
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Chattanooga, TN
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
Principal Investigator: Richard M. Novak, MD
Phone: 312-996-6763
University of Illinois at Chicago A major research university in the heart of one of...
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Chicago, IL
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Columbus, Ohio 43210
Principal Investigator: Susan L. Koletar, MD
Phone: 614-293-5666
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Columbus, OH
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1 Wyoming St,
Dayton, Ohio 45409
(937) 208-8000
Principal Investigator: Hari Polenakovik, MD
Phone: 937-208-2873
Miami Valley Hospital Miami Valley Hospital (MVH) is passionate about providing the most recent medical...
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Dayton, OH
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Detroit, Michigan 48202
Principal Investigator: Norman Markowitz, MD
Phone: 313-916-2575
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Detroit, MI
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El Palomar,
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: Mark Beilke
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Milwaukee, WI
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Newark, New Jersey 07103
Principal Investigator: Nila Dharan, MD
Phone: 973-972-2614
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Newark, NJ
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Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: Daniel E. Nixon, DO, PhD
Phone: 804-828-4510
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Rochester, Minnesota 55905
Principal Investigator: Zelalem Temesgen, MD
Phone: 507-255-7938
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Rochester, MN
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San Diego, California 92103
Principal Investigator: Robert Schooley, MD
Phone: 619-543-8080
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San Diego, CA
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Springfield, Massachusetts 01199
Principal Investigator: Amando Paez
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Springfield, MA
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Washington, District of Columbia 20037
Principal Investigator: Gary L. Simon, MD, PhD
Phone: 202-741-2234
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Washington, District of Columbia 20422
Principal Investigator: Fred M. Gordin, MD
Phone: 202-745-8301
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