Summary

for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion:
Robert Schooley

Description

Summary

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.

Official Title

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

Details

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.

Keywords

Influenza Novel Respiratory Virus-1 Middle Eastern Respiratory Syndrome Coronavirus (MERS-CoV) Novel Respiratory Virus-2 Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV) flu swine flu respiratory virus hospitalization MERS-CoV SARS-CoV Syndrome Virus Diseases Influenza, Human Severe Acute Respiratory Syndrome Coronavirus Infections Novel Respiratory Virus-1 Novel Respiratory Virus-2

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • Current imprisonment, or compulsory detention (involuntary incarceration) for treat of a psychiatric or physical illness.

Locations

  • UCSD Antiviral Research Center accepting new patients
    San Diego California 92103-8208 United States
  • Mayo Clinic accepting new patients
    Rochester Minnesota 55905 United States
  • University of Illinois at Chicago accepting new patients
    Chicago Illinois 60612 United States
  • Medical College of Wisconsin accepting new patients
    Milwaukee Wisconsin 53226 United States
  • University of Tennessee College of Medicine accepting new patients
    Chattanooga Tennessee 37403 United States
  • Miami Valley Hospital accepting new patients
    Dayton Ohio 45409 United States
  • The Ohio State University Medical Center accepting new patients
    Columbus Ohio 43210 United States
  • Henry Ford Health System accepting new patients
    Detroit Michigan 48202 United States
  • Duke University accepting new patients
    Durham North Carolina 27710 United States
  • Virginia Commonwealth University accepting new patients
    Richmond Virginia 23298 United States
  • George Washington Medical Faculty Associates accepting new patients
    Washington District of Columbia 20037 United States
  • Washington DC VA Medical Center accepting new patients
    Washington District of Columbia 20422 United States
  • Cooper University Hospital accepting new patients
    Camden New Jersey 08103 United States
  • New Jersey Medical School Adult Clinical Research Center accepting new patients
    Newark New Jersey 07103 United States
  • Cornell CRS accepting new patients
    New York New York 10010 United States
  • Montefiore Medical Center accepting new patients
    Bronx New York 10467 United States
  • Baystate Infectious Diseases Clinical Research accepting new patients
    Springfield Massachusetts 01199 United States
  • Brigham and Women's Hospital accepting new patients
    Boston Massachusetts 02115 United States
  • Hospital Nacional Arzobispo Loayza accepting new patients
    Lima 01 Peru
  • Hospital Nacional Guillermo Almenara Irigoyen accepting new patients
    Lima 13 Peru
  • Heatherwood and Wexham Park Hospitals NHS Foundation Trust accepting new patients
    Slough Berkshire United Kingdom
  • Brighton and Sussex University Hospitals NHS Trust accepting new patients
    Brighton East Sussex BN2 1ES United Kingdom
  • Churchill Hospital accepting new patients
    Headington Oxford OX3 9LJ United Kingdom
  • Sheffield Teaching Hospital NHS Foundation Trust accepting new patients
    Sheffield South Yorkshire S10 2JF United Kingdom
  • Bradford Teaching Hospitals NHS Foundation Trust accepting new patients
    Bradford West Yorkshire BD9 6RJ United Kingdom
  • St James's University Hospital accepting new patients
    Leeds West Yorkshire LS9 7TF United Kingdom
  • Newcastle General Hospital accepting new patients
    Newcastle upon Tyne NE4 6BE United Kingdom
  • Clinica Alemana currently not accepting new patients, but might later
    Santiago Chile
  • Fundacion Arriaran currently not accepting new patients, but might later
    Santiago Chile
  • Arhus Universitetshospital, Skejby accepting new patients
    Aarhus Denmark
  • CHIP accepting new patients
    Copenhagen Denmark
  • Hvidovre University Hospital, Department of Infectious Diseases accepting new patients
    Hvidovre Denmark
  • Odense University Hospital accepting new patients
    Odense Denmark
  • Centre Hospitalier Universitaire St. Pierre (C.H.U. St. Pierre) accepting new patients
    Brussels Belgium
  • Hospital Nacional Profesor Alejandro Posadas in progress, not accepting new patients
    El Palomar Buenos Aires Argentina
  • Instituto Medico Platense accepting new patients
    La Plata Buenos Aires Argentina
  • Hospital Universitario Austral accepting new patients
    Pilar Buenos Aires Argentina
  • Hospital Profesor Bernardo Houssay accepting new patients
    Vicente Lopez Buenos Aires Argentina
  • Sanatorio Britanico accepting new patients
    Rosario Santa Fe Argentina
  • CEMIC accepting new patients
    Buenos Aires Argentina
  • Hospital General de Agudos JM Ramos Mejia accepting new patients
    Buenos Aires Argentina
  • Hospital Interzonal General de Agudos Dr. Diego Paroissien in progress, not accepting new patients
    Buenos Aires Argentina
  • Hospital Italiano de Buenos Aires accepting new patients
    Buenos Aires Argentina
  • Hospital Privado Centro Medico de Cordoba accepting new patients
    Cordoba Argentina
  • Hospital Rawson accepting new patients
    Cordoba Argentina
  • Medizinische Universitatsklinik - Bonn, Immunologische Ambulanz CRS accepting new patients
    Bonn Germany
  • Klinik I fur Innere Medizin der Universitat zu Koln, Studienburo fur Infektiologie u. HIV accepting new patients
    Cologne Germany
  • Johann Wolfgang Goethe - University Hospital, Infektionsambulanz CRS accepting new patients
    Frankfurt Germany
  • Hospital Clinico San Carlos accepting new patients
    Madrid Spain
  • Hospital La Paz accepting new patients
    Madrid Spain
  • Hospital Universitario Gregorio Mara�on accepting new patients
    Madrid Spain
  • Hospital Universitario Infanta Leonor accepting new patients
    Madrid Spain
  • Hospital Txagorritxu accepting new patients
    Vitoria-Gasteiz Spain
  • 1st Dept of Critical Care Medicine and Pulmonary Services, Evangelismos Hospital accepting new patients
    Athens Greece
  • 1st Respiratory Medicine Dept, Athens Hosp for Diseases of the Chest "Sotiria Hospital" accepting new patients
    Athens Greece
  • Evangelismos General Hospital accepting new patients
    Athens Greece
  • Hippokration University General Hospital of Athens accepting new patients
    Athens Greece
  • St. Vincent's Hospital accepting new patients
    Darlinghurst New South Wales 2010 Australia
  • Westmead Hospital accepting new patients
    Westmead New South Wales 2145 Australia
  • The Alfred Hospital accepting new patients
    Melbourne Victoria 3004 Australia
  • Chulalongkorn University Hospital accepting new patients
    Bangkok 10330 Thailand
  • Khon Kaen University, Srinagarind Hospital accepting new patients
    Khon Kaen 40002 Thailand
  • Bamrasnaradura Institute accepting new patients
    Nonthaburi 11000 Thailand

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Minnesota - Clinical and Translational Science Institute
Links
INSIGHT website
ID
NCT01056185
Lead Scientist
Robert Schooley
Study Type
Observational
Last Updated
February 22, 2018