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Respiratory Virus Hospitalization Study (FLU 003 Plus)

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ClinicalTrials.gov Identifier: NCT01056185
Recruitment Status : Recruiting
First Posted : January 26, 2010
Last Update Posted : March 29, 2022
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
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 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.

Condition or disease
Influenza Novel Respiratory Virus-1 Middle Eastern Respiratory Syndrome Coronavirus (MERS-CoV) Novel Respiratory Virus-2 Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An International Observational Study to Characterize Adults Who Are Hospitalized With Influenza or Other Targeted Respiratory Viruses
Actual Study Start Date : August 2009
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

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)

Primary Outcome Measures :
  1. Death [ Time Frame: 60-day period following enrollment ]

Secondary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples With DNA

Serum, plasma, respiratory for all participants. For participants with a confirmed targeted non-influenza respiratory virus, attempts will be made to obtain a sample of the local specimen used to confirm diagnosis.

Whole blood for human genomics (only for FLU 003 Plus sites opting to also participate in INSIGHT Genomics and participant has signed an additional consent)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01056185

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Contact: James Neaton, Professor 612-626-9040 neato001@umn.edu
Contact: Eileen Denning, Coordinator 612-626-8049 edenning@umn.edu

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Sponsors and Collaborators
University of Minnesota
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
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Principal Investigator: James Neaton, Professor University of Minnesota - Dept Biostatistics
Additional Information:
World Health Organization (WHO), www.who.int/, accessed 26 August 2013
World Health Organization (WHO), Severe Acute Respiratory Syndrome (SARS), www.who.int/csr/sars/, accessed 26 August 2013

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT01056185    
Other Study ID Numbers: 0603M83587 FLU 003
First Posted: January 26, 2010    Key Record Dates
Last Update Posted: March 29, 2022
Last Verified: March 2022
Keywords provided by University of Minnesota:
swine flu
respiratory virus
Additional relevant MeSH terms:
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Virus Diseases
Influenza, Human
Coronavirus Infections
Severe Acute Respiratory Syndrome
Pathologic Processes
Respiratory Tract Infections
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Coronaviridae Infections
Nidovirales Infections