Clinical Trials
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.
Flu 003
- Overall study
- Study Sites (1)
Acronym | ISRCTN | EudraCT | NCT (clinicaltrials.gov) | DRKS |
---|---|---|---|---|
FLU 003 | NCT01056185 |
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
- Infectiology
- Influenza
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
Sponsor
CHIP Kopenhagen
- Tel. +45 35 45 5757
- Fax +45 35 45 5758
(National) Coordinating Investigator
Prof. Dr. med. Christoph Stephan