Surveillance of Influenza in Paediatric Intensive Care Units in Bavaria

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
GlaxoSmithKline
University of Wuerzburg
Information provided by:
University Children's Hospital, Wuerzburg
ClinicalTrials.gov Identifier:
NCT01286285
First received: January 19, 2011
Last updated: January 27, 2011
Last verified: January 2011
  Purpose

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.


Condition
Influenza
Acute Respiratory Infection

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by University Children's Hospital, Wuerzburg:

Primary Outcome Measures:
  • number and proportion of influenza-/ acute respiratory infection-associated hospitalizations to paediatric intensive care units [ Time Frame: outcome measure will be assessed between March and June 2012 for the whole study period (October 2010 - March 2012) ] [ Designated as safety issue: No ]
    • To evaluate the number of laboratory-confirmed influenza-associated (seasonal and new influenza A (H1N1)) hospitalizations to paediatric intensive care units in children ≤16 years of age
    • To evaluate the proportion of laboratory-confirmed influenza-associated (seasonal and new influenza A (H1N1)) hospitalizations to paediatric intensive care units in all children ≤16 years of age hospitalized to paediatric intensive care units with acute respiratory infections or suspected influenza


Secondary Outcome Measures:
  • health status at discharge [ Time Frame: outcome measure will be assessed between March and June 2012 for the whole study period (October 2010 - March 2012) ] [ Designated as safety issue: No ]
    - To evaluate the health status at discharge (outcome: alive without sequelae, alive with sequelae, deceased) in children ≤16 years of age hospitalized to paediatric intensive care units with laboratory-confirmed influenza (seasonal and new influenza A (H1N1))

  • severity of disease [ Time Frame: outcome measure will be assessed between March and June 2012 for the whole study period (October 2010 - March 2012) ] [ Designated as safety issue: No ]
    - To evaluate the severity of disease in children ≤16 years of age hospitalized to paediatric intensive care units with laboratory-confirmed influenza (seasonal and new influenza A (H1N1))

  • symptoms and complications [ Time Frame: outcome measure will be assessed between March and June 2012 for the whole study period (October 2010 - March 2012) ] [ Designated as safety issue: No ]
    • To evaluate the number of laboratory-confirmed influenza-associated (seasonal and new influenza A (H1N1)) cases treated with mechanical ventilation in children ≤16 years of age hospitalized to paediatric intensive care units
    • To evaluate symptoms, complications, risk factors, and therapeutic procedures in children ≤16 years of age hospitalized to paediatric intensive care units with laboratory-confirmed influenza (seasonal and new influenza A (H1N1))

  • comparison between influenza A and B as well as seasonal and new influenza [ Time Frame: outcome measure will be assessed between March and June 2012 for the whole study period (October 2010 - March 2012) ] [ Designated as safety issue: No ]
    • To compare age distribution, symptoms, complications, severity, risk factors, therapeutic procedures and outcome (fatalities, sequelae) between seasonal influenza A (and subtypes) and influenza B (and lineages) in children ≤16 years of age hospitalized to paediatric intensive care units
    • To compare age distribution, symptoms, complications, severity, risk factors, therapeutic procedures and outcome (fatalities, sequelae) between seasonal influenza and new influenza A (H1N1) in children ≤16 years of age hospitalized to paediatric intensive care units

  • comparison of different influenza tests [ Time Frame: outcome measure will be assessed between March and June 2012 for the whole study period (October 2010 - March 2012) ] [ Designated as safety issue: No ]
    - To evaluate the positive rate of other microbiological influenza tests than polymerase chain reaction (rapid test, immunoflourescence etc, if locally performed by hospitals/laboratories) in children ≤16 years of age hospitalized to paediatric intensive care units

  • number of acute respiratory infection-associated hospitalizations to paediatric intensive care units, comparison with influenza-associated hospitalizations to paediatric intensive care units [ Time Frame: outcome measure will be assessed between March and June 2012 for the whole study period (October 2010 - March 2012) ] [ Designated as safety issue: No ]
    • To evaluate the number and proportion of hospitalizations to paediatric intensive care units admitted due to other acute respiratory infections in children ≤16 years of age
    • To compare age distribution, symptoms, complications, severity, risk factors, therapeutic procedures, and outcome (fatalities/sequelae) between children hospitalized to paediatric intensive care units with influenza and children hospitalized to paediatric intensive care units due to other acute respiratory infections

  • number of hospitalizations related to the corresponding population [ Time Frame: outcome measure will be assessed between March and June 2012 for the whole study period (October 2010 - March 2012) ] [ Designated as safety issue: No ]
    • To estimate the (minimum) incidence of laboratory-confirmed influenza (seasonal and new influenza A (H1N1)) hospitalizations to paediatric intensive care units in Bavaria in children ≤16 years of age
    • To estimate the (minimum) incidence of laboratory-confirmed hospitalizations to paediatric intensive care units in Bavaria in children ≤16 years of age due to other acute respiratory infections


Biospecimen Retention:   Samples With DNA

Naso-pharyngeal swab, if not available nasal wash or other respiratory secretion (only if collected routinely by the hospital)


Estimated Enrollment: 1140
Study Start Date: October 2010
Estimated Study Completion Date: March 2012
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   1 Month to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children ≤16 years of age, in hospitals with paediatric intensive care units or paediatric intensive care beds in Bavaria, Germany

Criteria

Inclusion Criteria:

  • Male or female subjects, ≤16 years of age at the time of paediatric intensive care unit admittance. A subject will become ineligible on his/her 17th birthday
  • All patients for whom a written Informed Consent Form for study participation can be obtained
  • Children presenting with suspected acute respiratory infection of the upper or lower respiratory tract, with acute respiratory infection-related symptoms, e.g. sore throat (in children ≥ 3 years old), coryza (runny nose), cough etc. or B) Children already admitted to the paediatric intensive care unit without apparent acute respiratory infection/influenza-related symptoms that develop acute respiratory infection/influenza-related symptoms within the paediatric intensive care unit or
  • Children admitted to the paediatric intensive care unit with suspected influenza (even without respiratory symptoms, e.g. with neurological symptoms) or
  • Children admitted to the paediatric intensive care unit with potential influenza-triggered complications and laboratory-confirmed influenza ≤14 days before paediatric intensive care unit admission (by polymerase chain reaction or other influenza test methods)
  • Additionally, all children with confirmed / suspected acute respiratory infection/ influenza that died already during admission to the paediatric hospital/ the paediatric intensive care unit will be included (a pseudonymous autopsy report including laboratory analyses (if available) will be requested for these patients).

Exclusion Criteria:

none

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01286285

Locations
Germany
University Children's Hospital Wuerzburg
Wuerzburg, Bavaria, Germany
Sponsors and Collaborators
University Children's Hospital, Wuerzburg
GlaxoSmithKline
University of Wuerzburg
Investigators
Principal Investigator: Johannes G. Liese, MD, MSc University Children's Hospital Wuerzburg, Paediatric Infectiology and Immunology, Josef-Schneider-Str. 2, 97080 Wuerzburg, Germany
  More Information

Publications:
Poehling, K.A., Edwards, K.M., Weinberg, G.A., Szilagyi, P., Staat, M.A., Iwane, M.K., Bridges, C.B., Grijalva, C.G., Zhu, Y., Bernstein, D.I., Herrera, G., Erdman, D., Hall, C.B., Seither, R., and Griffin, M.R., The underrecognized burden of influenza in young children. N Engl J Med 355 (2006) 31-40
Kumar, A., Zarychanski, R., Pinto, R., Cook, D.J., Marshall, J., Lacroix, J., Stelfox, T., Bagshaw, S., Choong, K., Lamontagne, F., Turgeon, A.F., Lapinsky, S., Ahern, S.P., Smith, O., Siddiqui, F., Jouvet, P., Khwaja, K., McIntyre, L., Menon, K., Hutchison, J., Hornstein, D., Joffe, A., Lauzier, F., Singh, J., Karachi, T., Wiebe, K., Olafson, K., Ramsey, C., Sharma, S., Dodek, P., Meade, M., Hall, R., and Fowler, R.A., Critically ill patients with 2009 influenza A(H1N1) infection in Canada. Jama 302 (2009) 1872-9.

Responsible Party: Prof. Dr. med. Johannes G. Liese, MSc, University Children's Hospital Wuerzburg, Germany
ClinicalTrials.gov Identifier: NCT01286285     History of Changes
Other Study ID Numbers: UNIV HOSP WUERZBURG 7106877
Study First Received: January 19, 2011
Last Updated: January 27, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by University Children's Hospital, Wuerzburg:
influenza
acute respiratory infections
paediatric
intensive care units
epidemiology

Additional relevant MeSH terms:
Influenza, Human
Respiratory Tract Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Infection

ClinicalTrials.gov processed this record on August 28, 2014