Respiratory Virus Outpatient Study (FLU 002 Plus)
- Conditions
- Influenza and Other Novel Respiratory Viruses
- Registration Number
- NCT01056354
- Lead Sponsor
- University of Minnesota
- Brief Summary
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
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11719
- 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
- Current imprisonment, or compulsory detention (involuntary incarceration) for treatment of a psychiatric or physical illness.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Death or Hospitalization 14-day period following enrollment Death or hospitalization within 14 days of enrollment or the development of one severe complication.
- Secondary Outcome Measures
Name Time Method Days of work/school lost, duration of symptoms, use of antivirals 14 days
Trial Locations
- Locations (68)
FUNCEI
🇦🇷Buenos Aires, Argentina
Infectious Diseases Associates NW FL, PA
🇺🇸Pensacola, Florida, United States
George Washington Medical Faculty Associates
🇺🇸Washington, D.C., District of Columbia, United States
Hospital Interzonal General de Agudos Dr. Diego Paroissien
🇦🇷La Matanza, Buenos Aires, Argentina
Interchange General Practice
🇦🇺Canberra, Australian Capital Territory, Australia
Washington DC VA Medical Center
🇺🇸Washington, D.C., District of Columbia, United States
Hospital Privado Centro Medico de Cordoba
🇦🇷Cordoba, Argentina
Denver Public Health
🇺🇸Denver, Colorado, United States
Fundacion Arriaran
🇨🇱Santiago, Chile
Cornell CRS
🇺🇸New York, New York, United States
Hospital General de Agudos JM Ramos Mejia
🇦🇷Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
🇦🇷Buenos Aires, Argentina
Bronx-Lebanon Hospital Center
🇺🇸The Bronx, New York, United States
University of North Texas Health Science Center
🇺🇸Fort Worth, Texas, United States
Hospital Nacional Profesor Alejandro Posadas
🇦🇷El Palomar, Buenos Aires, Argentina
Instituto Medico Platense
🇦🇷La Plata, Buenos Aires, Argentina
University Clinic of General Practice
🇩🇰Copenhagen, Denmark
Hospital Profesor Bernardo Houssay
🇦🇷Vicente Lopez, Buenos Aires, Argentina
CEMIC
🇦🇷Buenos Aires, Argentina
Hospital Rawson
🇦🇷Cordoba, Argentina
Centre Hospitalier Universitaire St. Pierre (C.H.U. St. Pierre)
🇧🇪Brussels, Belgium
Pontificia Universidad Catolica de Chile
🇨🇱Santiago, Chile
1st Respiratory Medicine Dept, Athens Hosp for Diseases of the Chest "Sotiria Hospital"
🇬🇷Athens, Greece
Hospital Nacional Edgardo Rebagliati Martins
🇵🇪Lima, Peru
Hospital Nacional Guillermo Almenara Irigoyen
🇵🇪Lima, Peru
Holdsworth House Medical Practice
🇦🇺Darlinghurst, New South Wales, Australia
Klinik I fur Innere Medizin der Universitat zu Koln, Studienburo fur Infektiologie u. HIV
🇩🇪Cologne, Germany
Chulalongkorn University Hospital
🇹🇭Bangkok, Thailand
Khon Kaen University, Srinagarind Hospital
🇹🇭Khon Kaen, Thailand
St James's University Hospital
🇬🇧Leeds, West Yorkshire, United Kingdom
Prahran Market Clinic
🇦🇺Melbourne, Victoria, Australia
Ifi - Studien und Projekte GmbH
🇩🇪Hamburg, Germany
Hospital Universitario y Politécnico La Fe
🇪🇸Valencia, Spain
Northside Clinic
🇦🇺North Fitzroy, Victoria, Australia
Clinica Alemana
🇨🇱Santiago, Chile
Practimed Medisch Centrum Tessenderlo
🇧🇪Tessenderlo, Belgium
Medizinische Universitatsklinik - Bonn, Immunologische Ambulanz CRS
🇩🇪Bonn, Germany
1st Dept of Critical Care Medicine and Pulmonary Services, Evangelismos Hospital
🇬🇷Athens, Greece
Arhus Universitetshospital, Skejby
🇩🇰Aarhus, Denmark
Johann Wolfgang Goethe - University Hospital, Infektionsambulanz CRS
🇩🇪Frankfurt, Germany
CHIP
🇩🇰Copenhagen, Denmark
Rigshospitalet, Infektionsmedicinsk ambulatorium 8622
🇩🇰Copenhagen, Denmark
West Tallinn Central Hospital Infectious Diseases
🇪🇪Tallinn, Estonia
Evangelismos General Hospital
🇬🇷Athens, Greece
Hippokration University General Hospital of Athens
🇬🇷Athens, Greece
Wojewodzki Szpital Zakazny
🇵🇱Warsaw, Poland
EMC Instytut Medyczny SA
🇵🇱Wroclaw, Poland
Hospital Txagorritxu
🇪🇸Vitoria-Gasteiz, Spain
Norfolk and Norwich University Hospital
🇬🇧Norwich, Norfolk, United Kingdom
Bradford Teaching Hospitals NHS Foundation Trust
🇬🇧Bradford, West Yorkshire, United Kingdom
Bamrasnaradura Institute
🇹🇭Nonthaburi, Thailand
National Hospital Organization Nagoya Medical Center
🇯🇵Nagoya, Japan
Hospital Nacional Arzobispo Loayza
🇵🇪Lima, Peru
Churchill Hospital
🇬🇧Headington, Oxford, United Kingdom
Asociacion Civil IMPACTA Salud y Educacion
🇵🇪Lima, Peru
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
UCSD Antiviral Research Center
🇺🇸San Diego, California, United States
New Jersey Medical School Adult Clinical Research Center
🇺🇸Newark, New Jersey, United States
Duke University
🇺🇸Durham, North Carolina, United States
University of Tennessee College of Medicine
🇺🇸Chattanooga, Tennessee, United States
Houston AIDS Research Team
🇺🇸Houston, Texas, United States
Newland Immunology Center of Excellence (NICE)
🇺🇸Southfield, Michigan, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
UNC AIDS Clinical Trials Unit
🇺🇸Chapel Hill, North Carolina, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
CAICI (Instituto Centralizado de Assistencia e Investigacion Clinica Integral)
🇦🇷Rosario, Santa Fe, Argentina
Sanatorio Britanico
🇦🇷Rosario, Santa Fe, Argentina
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia