Respiratory Virus Outpatient Study (FLU 002 Plus)



Status:Recruiting
Conditions:Influenza, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:August 2009
End Date:August 2016
Contact:James Neaton, Professor
Email:neato001@umn.edu
Phone:612-626-9040

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An International Observational Study to Characterize Adults 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 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

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 reverse transcriptase polymerase
chain reaction (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.

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.
We found this trial at
18
sites
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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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3500 Camp Bowie Boulevard
Fort Worth, Texas 76107
Principal Investigator: Frank Filipetto
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Fort Worth, TX
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Bronx, New York 10457
Principal Investigator: Richard Cindrich
Phone: 718-960-1212
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Bronx, NY
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Chapel Hill, North Carolina 27514
Principal Investigator: Christopher Hurt
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Chapel Hill, NC
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Chattanooga, Tennessee 37403
Principal Investigator: Stephen Adams, 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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Denver, Colorado 80204
Principal Investigator: Edward Gardner, MD
Phone: 303-602-8740
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Denver, CO
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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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Houston, Texas 77030
Principal Investigator: Karen J. Vigil
Phone: 713-500-6703
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Houston, TX
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New York, New York 10011
Principal Investigator: Marshall Glesby
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New York, NY
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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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Pensacola, Florida 32504
Principal Investigator: Barbara He Wade, MD, FACP
Phone: 850-912-8301
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Pensacola, FL
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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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Richmond, VA
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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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Southfield, Michigan 48075
Principal Investigator: Rodger D. MacArthur, MD
Phone: 734-516-0204
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Southfield, MI
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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,
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Washington, District of Columbia 20422
Principal Investigator: Fred M. Gordin, MD
Phone: 202-745-8301
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