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Flu 003

FLU 003NCT01056185

An International Observational Study to Characterize Adults Who Are Hospitalized with Complications of Influenza A Pandemic (H1N1v).

Status: Active

Purpose / Objectives

Primary Outcome

The purpose of this observational study is to describe the characteristics and outcomes over a 60-day follow-up period of participants with influenzy A pandemic H1N1v who are hospitalized with severe and/or complicated influenza A in geographically diverse locations. Specific objectives are to estimate the percentage of patients who die,  to obtain information on risk factors for mortality, and to establisch 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. This information will be usted to guide policyakers and to design future studies.

Secondary Outcomes

not applicable


Patients who are hospitalized to to Influenza A H1N1v

Target population


Influenza Hospitalisation



Inclusion criteria

≥18 years old

a local diagnosis of influenza A (confirmed or suspect)

be hospitalized for severe complicated influenza


Exclusion criteria

not applicable

Study design

  • Multicenter
  • Prospective


not applicable

Documents (password protected)

Responsibilities in overall study

CHIP Kopenhagen

  • Tel. +45 35 45 5757
  • Fax +45 35 45 5758

National Coordinating Investigator

PD Dr. med. Christoph Stephan