Oseltamivir Infant Influenza Safety Study

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Barbara Rath, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01286142
First received: January 24, 2011
Last updated: October 13, 2011
Last verified: October 2011
  Purpose

In June 2009, the World Health Organization (WHO) declared a global pandemic of influenza A (H1N1). Although little is known about the pandemic influenza strain in children, during previous pandemics and influenza seasons children less than one year of age were shown to be at higher risk of influenza complications than older children. In light of the 2009 H1N1 pandemic situation, the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Health Canada issued emergency authorizations for oseltamivir to be used to treat and prevent influenza in infants under 1 year of age. It is anticipated that oseltamivir use in infants will dramatically increase due to the new authorizations for use in this population and high prevalence of H1N1 influenza circulating in the population. Ongoing safety surveillance is critical and this study will provide further data for evaluating the risk/benefit ratio of prescribing oseltamivir to this population in the current milieu of both seasonal and pandemic influenza viruses circulating in the population. The study will also provide useful information on the dose and duration of treatment used in clinical practice and their relationship to adverse events.


Condition
Influenza, Human

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Observational Safety Study in Children <= 24 Months of Age Receiving Oseltamivir for the Treatment or Prophylaxis of Influenza Infection

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Number of subjects with Adverse Events [ Time Frame: Study Day 7 post-baseline ] [ Designated as safety issue: Yes ]
    Information on the number of subjects with AEs will be collected at 7 days post-baseline. AEs include influenza symptoms and associated complications solicited from parent/legal guardian; secondary complications of influenza reported by physician, including otitis media and bacterial infections; and any other non-serious and serious AEs.

  • Number of subjects with Adverse Events [ Time Frame: Study Day 30 post-baseline ] [ Designated as safety issue: Yes ]
    Information on the number of subjects with AEs will be collected at 30 days post-baseline. AEs include influenza symptoms and associated complications solicited from parent/legal guardian; secondary complications of influenza reported by physician, including otitis media and bacterial infections; and any other non-serious and serious AEs.


Secondary Outcome Measures:
  • Number of subjects treated with oseltamivir [ Time Frame: Day 30 post baseline ] [ Designated as safety issue: Yes ]
    Data on dosage and duration of treatment with oseltamivir in real-world practice are collected. The aim is to examine the relationship of adverse events to the regimen of oseltamivir.

  • Number of subjects with drug-resistant virus [ Time Frame: Day 30 post-baseline ] [ Designated as safety issue: No ]
    Data on oseltamivir resistance are collected (as reported only)


Estimated Enrollment: 900
Study Start Date: December 2009
Study Completion Date: September 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Influenza treatment with oseltamivir
Patients 24 months of age and younger initially presenting with confirmed or presumed influenza A or B infection treated with oseltamivir.
Influenza prophylaxis with oseltamivir
Patients 24 months of age and younger prescribed oseltamivir for influenza prophylaxis
Influenza patients with no antiviral treatment
A comparator group of patients 24 months of age and younger presenting with confirmed or presumed influenza A or B and not treated with any influenza antiviral.

Detailed Description:

This study is a prospective, observational, multicenter short-term safety study of the use of oseltamivir (prophylaxis or treatment) in children 24 months of age or younger. An internal comparator group of children diagnosed with influenza and not treated with antiviral medications will be enrolled. The study includes a 30-day follow-up period and will be conducted in multiple sites in multiple countries within the European Union. The study will cover two consecutive influenza seasons: 01 October 2009 - 31 May 2010 and 01 October 2010 - 31 May 2011. Data collection may be interrupted in the interim period between influenza seasons (June 1, 2010 - September 30, 2010), depending on whether the influenza season follows the expected cycle.

  Eligibility

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study will be conducted in multiple sites in multiple countries within the European Union. Initially, five countries (United Kingdom, Austria, Finland, Poland, Germany) are selected for inclusion, but additional countries in Europe, are likely to be added. It is estimated that 3-12 sites per country will be enrolled, with a target of at least 900 patients. If additional countries are added, the number of sites/patients recruited per country will be adjusted accordingly.

Criteria

Inclusion Criteria:

  • 24 months of age or younger at time of enrollment
  • Diagnosis of influenza A or B (suspected* or confirmed by viral testing) either treated with oseltamivir or with no antivirals OR prescribed oseltamivir for post-exposure influenza prophylaxis
  • Parent/legal guardian willing to provide informed consent and be contacted by telephone as part of follow-up

Exclusion Criteria:

  • Patients will be excluded if treated with an influenza antiviral other than oseltamivir, including amantadine, rimantadine, or zanamivir.

    • Suspected influenza is defined as an acute febrile illness characterized by the presence of fever and 1 or more of the following symptoms: cough, coryza/nasal congestion or sore throat.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01286142

Locations
Germany
Charite University Berlin
Berlin, Germany
Sponsors and Collaborators
Charite University, Berlin, Germany
Hoffmann-La Roche
Investigators
Principal Investigator: Barbara Rath, MD Charite University Berlin, Department of Pediatrics (Div. of Pneumonology and Immunology)
  More Information

Publications:
Responsible Party: Barbara Rath, Principle Investigator, Pediatric Infectious Diseases & Vaccines, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01286142     History of Changes
Other Study ID Numbers: NV25182
Study First Received: January 24, 2011
Last Updated: October 13, 2011
Health Authority: European Union: European Medicines Agency

Keywords provided by Charite University, Berlin, Germany:
Prospective, Observational Safety Study

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Oseltamivir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014