Influenza Clinical Trial
Official title:
An Active, Epidemiological Surveillance Study on Influenza-related Hospitalizations to Intensive Care Units and Fatalities in Paediatric Hospitals in Bavaria Covering the Influenza Seasons 2010/2011 and 2011/2012
The purpose of the study is to assess the number of severe, laboratory-confirmed influenza in children hospitalized to paediatric intensive care units. Furthermore, the proportion of these children from all children hospitalized to paediatric intensive care units with acute respiratory infections will be established.
Accurate epidemiological data on severe influenza-associated hospitalizations and fatalities
in children are lacking in Germany. The purpose of this study is primarily, to assess the
number of severe, laboratory-confirmed influenza in children hospitalized to paediatric
intensive care units due to suspected acute respiratory infections/ influenza/
influenza-triggered complications and in children developing influenza during paediatric
intensive care unit hospitalization, as well as the number of influenza-associated
fatalities. In addition we aim at assessing clinical features, severity, risk factors,
complications, diagnostic procedures, treatment and outcome of severe, laboratory-confirmed
influenza (and other acute respiratory infections) in these children. Another objective is
to estimate the proportion of laboratory-confirmed influenza cases in all children
hospitalized to paediatric intensive care units with acute respiratory infections and to
evaluate the number and proportion of paediatric intensive care unit hospitalizations due to
other viral acute respiratory infections. Additional aims are to estimate the (minimum)
incidence of severe influenza-associated hospitalizations in Bavarian children and to
estimate the (minimum) incidences of other acute respiratory infections.
Ideally, this study will be conducted between October 2010 and March 2012 in all Bavarian
(Germany) hospitals with paediatric intensive care units or paediatric intensive care beds
(neonatology excluded). To optimize reporting there will be one study physician at each site
responsible for documentation, diagnostic procedures and queries. The local study physician
will receive an initiation visit at the start of each season, and will be contacted by the
study coordination (situated at the University Children's Hospital in Wuerzburg) bi-weekly
by phone. This local study physician summarizes the paediatric intensive care unit
admittance in a log sheet, documents epidemiological, demographical, and clinical data in a
questionnaire for all suspected acute respiratory infections/influenza patients with
parental informed consent (pseudonymous data only), and draws a nasopharyngeal swab or -wash
if indicated as routine procedure. A sample will be sent to the central laboratory
(Institute for Virology and Immunobiology, University of Wuerzburg) for analysis
(influenza-polymerase chain reaction, influenza virus subtyping, other viral acute
respiratory infections (respiratory syncytial virus, parainfluenza 1-4, humane
metapneumovirus, adenoviruses, rhinoviruses, enteroviruses). The central laboratory will
analyse the samples timely and report the results to the respective study site. Additional
influenza-tests may also be performed by the local laboratory, at the discretion of the
hospitals. All tests, locally and performed in Wuerzburg, and their outcome should be
reported in the questionnaire.
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