Respiratory Virus Hospitalization Study (FLU 003 Plus)

February 1, 2024 updated by: University of Minnesota

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Rebecca Schoenecker, MPH
  • Phone Number: 612-625-7292
  • Email: webe0376@umn.edu

Study Locations

  • Argentina
      • Buenos Aires, Argentina
      • Buenos Aires, Argentina
        • Recruiting
        • Hospital Italiano de Buenos Aires
        • Contact:
        • Principal Investigator:
          • Laura Barcan
      • Buenos Aires, Argentina
        • Recruiting
        • Hospital General de Agudos JM Ramos Mejía
        • Contact:
        • Principal Investigator:
          • Marcelo H. Losso, MD
      • Buenos Aires, Argentina
        • Active, not recruiting
        • Hospital Interzonal General de Agudos Dr. Diego Paroissien
      • Cordoba, Argentina
        • Recruiting
        • Hospital Privado Centro Medico de Cordoba
        • Contact:
        • Principal Investigator:
          • Abel Hu Zarate
      • Cordoba, Argentina
        • Recruiting
        • Hospital Rawson
        • Contact:
        • Principal Investigator:
          • Daniel Om David, MD
    • Buenos Aires
      • El Palomar, Buenos Aires, Argentina
        • Active, not recruiting
        • Hospital Nacional Profesor Alejandro Posadas
      • La Plata, Buenos Aires, Argentina
        • Recruiting
        • Instituto Medico Platense
        • Contact:
        • Principal Investigator:
          • Analia Mykietiuk
      • Pilar, Buenos Aires, Argentina
        • Recruiting
        • Hospital Universitario Austral
        • Contact:
        • Principal Investigator:
          • Rodolfo Quiros, MD
      • Vicente Lopez, Buenos Aires, Argentina
        • Recruiting
        • Hospital Profesor Bernardo Houssay
        • Contact:
        • Principal Investigator:
          • Gustavo Da Lopardo, MD
    • Santa Fe
      • Rosario, Santa Fe, Argentina
  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Recruiting
        • St. Vincent's Hospital
        • Contact:
        • Principal Investigator:
          • David A. Cooper, MD, DSc
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • Westmead Hospital
        • Contact:
        • Principal Investigator:
          • Dominic Dwyer
    • Victoria
      • Melbourne, Victoria, Australia, 3004
  • Belgium
      • Brussels, Belgium
        • Recruiting
        • Centre Hospitalier Universitaire St. Pierre (C.H.U. St. Pierre)
        • Contact:
        • Principal Investigator:
          • Nathan Clumeck, MD, PhD
  • Chile
      • Santiago, Chile
        • Suspended
        • Clínica Alemana
      • Santiago, Chile
        • Suspended
        • Fundacion Arriaran
  • Denmark
      • Aarhus, Denmark
        • Recruiting
        • Arhus Universitetshospital, Skejby
        • Contact:
          • Lars Oestergaard, MD,PhD, DMSc
          • Phone Number: 45.89.49.84.93
          • Email: larsoest@rm.dk
        • Principal Investigator:
          • Lars Oestergaard, MD,PhD, DMSc
      • Copenhagen, Denmark
        • Recruiting
        • CHIP
        • Contact:
        • Principal Investigator:
          • Jens D. Lundgren, MD, DMSc
      • Hvidovre, Denmark
        • Recruiting
        • Hvidovre University Hospital, Department of Infectious Diseases
        • Contact:
        • Principal Investigator:
          • Gitte Kronborg
      • Odense, Denmark
  • Germany
      • Bonn, Germany
        • Recruiting
        • Medizinische Universitatsklinik - Bonn, Immunologische Ambulanz CRS
        • Contact:
        • Principal Investigator:
          • Jurgen Rockstroh
      • Cologne, Germany
        • Recruiting
        • Klinik I fur Innere Medizin der Universitat zu Koln, Studienburo fur Infektiologie u. HIV
        • Contact:
        • Principal Investigator:
          • Gerd Fatkenheuer, MD
      • Frankfurt, Germany
        • Recruiting
        • Johann Wolfgang Goethe - University Hospital, Infektionsambulanz CRS
        • Contact:
        • Principal Investigator:
          • Christoph Stephan
  • Greece
      • Athens, Greece
        • Recruiting
        • Evangelismos General Hospital
        • Contact:
        • Principal Investigator:
          • Athanasios Skoutelis
      • Athens, Greece
        • Recruiting
        • 1st Dept of Critical Care Medicine and Pulmonary Services, Evangelismos Hospital
        • Contact:
        • Principal Investigator:
          • Ioannis Kalomenidis
      • Athens, Greece
        • Recruiting
        • 1st Respiratory Medicine Dept, Athens Hosp for Diseases of the Chest "Sotiria Hospital"
        • Contact:
        • Principal Investigator:
          • Nikolaos Koulouris
      • Athens, Greece
        • Recruiting
        • Hippokration University General Hospital of Athens
        • Contact:
        • Principal Investigator:
          • Helen Sambatakou, MD, PhD
  • Peru
      • Lima, Peru, 01
        • Recruiting
        • Hospital Nacional Arzobispo Loayza
        • Contact:
        • Principal Investigator:
          • Yvett Pinedo
      • Lima, Peru, 13
        • Recruiting
        • Hospital Nacional Guillermo Almenara Irigoyen
        • Contact:
        • Principal Investigator:
          • Juan Vega
  • Spain
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Infanta Leonor
        • Contact:
        • Principal Investigator:
          • Pablo Ryan, MD
      • Madrid, Spain
        • Recruiting
        • Hospital Clinico San Carlos
        • Contact:
        • Principal Investigator:
          • Vicente Estrada, MD
      • Madrid, Spain
        • Recruiting
        • Hospital La Paz
        • Contact:
        • Principal Investigator:
          • Jose Ra Pano-Pardo
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Gregorio Mara�on
        • Contact:
        • Principal Investigator:
          • Eduardo Fernandez-Cruz, MD, PhD
      • Vitoria-Gasteiz, Spain
  • Thailand
      • Bangkok, Thailand, 10330
        • Recruiting
        • Chulalongkorn University Hospital
        • Contact:
        • Principal Investigator:
          • Kiat Ruxrungtham, MD, MSc
      • Khon Kaen, Thailand, 40002
        • Recruiting
        • Khon Kaen University, Srinagarind Hospital
        • Principal Investigator:
          • Ploenchan Chetchotisakd, MD
        • Contact:
      • Nonthaburi, Thailand, 11000
        • Recruiting
        • Bamrasnaradura Institute
        • Contact:
        • Principal Investigator:
          • Weerawat Manosuthi
  • United Kingdom
      • Newcastle upon Tyne, United Kingdom, NE4 6BE
        • Recruiting
        • Newcastle General Hospital
        • Contact:
        • Principal Investigator:
          • Ashley Price
    • Berkshire
      • Slough, Berkshire, United Kingdom
        • Recruiting
        • Heatherwood and Wexham Park Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Jane Democratis
    • East Sussex
      • Brighton, East Sussex, United Kingdom, BN2 1ES
        • Recruiting
        • Brighton and Sussex University Hospitals NHS Trust
        • Contact:
        • Principal Investigator:
          • Melanie Newport
    • Oxford
      • Headington, Oxford, United Kingdom, OX3 9LJ
        • Recruiting
        • Churchill Hospital
        • Contact:
        • Principal Investigator:
          • Brian J. Angus, MD
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2JF
        • Recruiting
        • Sheffield Teaching Hospital NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • David Dockrell, MD, FRCPI
    • West Yorkshire
      • Bradford, West Yorkshire, United Kingdom, BD9 6RJ
        • Recruiting
        • Bradford Teaching Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Ben Jeffs
      • Leeds, West Yorkshire, United Kingdom, LS9 7TF
        • Recruiting
        • St James's University Hospital
        • Principal Investigator:
          • Jane Minton
        • Contact:
  • United States
    • California
      • San Diego, California, United States, 92103-8208
        • Recruiting
        • UCSD Antiviral Research Center
        • Contact:
        • Principal Investigator:
          • Robert Schooley, MD
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • Recruiting
        • Washington DC VA medical Center
        • Contact:
        • Principal Investigator:
          • Fred M. Gordin, MD
      • Washington, District of Columbia, United States, 20037
        • Recruiting
        • George Washington Medical Faculty Associates
        • Contact:
        • Principal Investigator:
          • Gary L. Simon, MD, PhD
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois at Chicago
        • Contact:
        • Principal Investigator:
          • Richard M. Novak, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Contact:
        • Principal Investigator:
          • Namrata Patil, MD, MPH
      • Springfield, Massachusetts, United States, 01199
        • Recruiting
        • Baystate Infectious Diseases Clinical Research
        • Contact:
        • Principal Investigator:
          • Amando Paez
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health System
        • Contact:
        • Principal Investigator:
          • Norman Markowitz, MD
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Zelalem Temesgen, MD
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Recruiting
        • Cooper University Hospital
        • Contact:
        • Principal Investigator:
          • Raquel Nahra, MD
      • Newark, New Jersey, United States, 07103
        • Recruiting
        • New Jersey Medical School Adult Clinical Research Center
        • Contact:
        • Principal Investigator:
          • Nila Dharan, MD
    • New York
      • Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
        • Contact:
        • Principal Investigator:
          • Paul Riska, M.D.
      • New York, New York, United States, 10010
        • Recruiting
        • Cornell ID-CRU
        • Principal Investigator:
          • Mirella Salvatore, MD
        • Contact:
    • North Carolina
      • Durham, North Carolina, United States, 27710
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University Medical Center
        • Contact:
        • Principal Investigator:
          • Susan L. Koletar, MD
      • Dayton, Ohio, United States, 45409
        • Recruiting
        • Miami Valley Hospital
        • Contact:
        • Principal Investigator:
          • Hari Polenakovik, MD
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Recruiting
        • University of Tennessee College of Medicine
        • Contact:
        • Principal Investigator:
          • John Gunter, MD
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University
        • Contact:
        • Principal Investigator:
          • Daniel E. Nixon, DO, PhD
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
        • Principal Investigator:
          • Mark Beilke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult patients who are hospitalized with a diagnosis (confirmed or suspected) of influenza or a targeted non-influenza viral respiratory infection, as soon as possible after the suspected diagnosis is made. Participants may have already been admitted to the hospital at the study site or may have been previously seen at another hospital where the diagnosis of influenza or infection with a targeted respiratory virus was made.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Influenza
Influenza A and subtypes such as H3N2 and 2009 H1N1 or influenza B
Novel Respiratory Virus-1
MERS-CoV (Middle East Respiratory Syndrome Coronavirus
Novel Respiratory Virus-2
SARS-CoV (Severe Acute Respiratory Syndrome Coronavirus)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Death
Time Frame: 60-day period following enrollment
60-day period following enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
Recovery from influenza illness (including days lost from normal activities) duration of hospitalization, days in intensive care, days of mechanical ventilation, days of dialysis, pregnancy outcome
Time Frame: approximately 60 days
approximately 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Cavan Reilly, PhD, University of Minnesota - Dept Biostatistics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2009

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 25, 2010

First Submitted That Met QC Criteria

January 25, 2010

First Posted (Estimated)

January 26, 2010

Study Record Updates

Last Update Posted (Estimated)

February 2, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0603M83587 FLU 003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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