As an infrastructure at the German Center for Infection Research (DZIF), the Clinical Trial Unit tracks DZIF's study activities in the “Healex Site Management System (SMS)”. Studies are sorted by indication and are continuously updated.

The study register has recently been expanded to include the category “COVID-19”. For the first time, not only DZIF study activities are presented here: In order to provide a comprehensive overview in the current pandemic situation of planned and already active COVID-19 studies in Germany, the Clinical Trial Unit is cooperating with researchers from various German Centers for Health Research and other networks.

For researchers: If your study is not yet included in our portal, please contact the project management of the Clinical Trial Unit (angela.steinbach@uk-koeln.de or vassiliki.dimitriou@uk-koeln.de).

Flu 003

AcronymISRCTNEudraCTNCT (clinicaltrials.gov)DRKS
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

Diagnosis

Patients who are hospitalized to to Influenza A H1N1v

Target population

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)

Responsibilities in overall study

CHIP Kopenhagen

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

National Coordinating Investigator

PD Dr. med. Christoph Stephan