Status Acronym ISRCTN EudraCT NCT (clinicaltrials.gov) DRKS
Active (Recruitment Closed) FLU 003 NCT01056185

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

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

Diagnosis

  • Infectiology
  • Influenza

Patients who are hospitalized to to Influenza A H1N1v

Target population

Disease stage

Influenza Hospitalisation

Age

18-99

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

Intervention

not applicable

Documents (password protected)

Go to download area

Networks

Responsibilities in overall study

Sponsor

CHIP Kopenhagen

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

(National) Coordinating Investigator

Prof. Dr. med. Christoph Stephan