Oseltamivir Infant Influenza Safety Study
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.
|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|
- 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.
- 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)
|Study Start Date:||December 2009|
|Study Completion Date:||September 2011|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
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.
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.
|Charite University Berlin|
|Principal Investigator:||Barbara Rath, MD||Charite University Berlin, Department of Pediatrics (Div. of Pneumonology and Immunology)|