Oseltamivir Infant Influenza Safety Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Observational Safety Study in Children <= 24 Months of Age Receiving Oseltamivir for the Treatment or Prophylaxis of Influenza Infection

Conditions
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Influenza, Human

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Influenza treatment with oseltamivir<br>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<br>Patients 24 months of age and younger prescribed oseltamivir for influenza prophylaxis | |
| Influenza patients with no antiviral treatment<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with Adverse Events | 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. | Study Day 7 post-baseline | 
| Number of subjects with Adverse Events | 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. | Study Day 30 post-baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects treated with oseltamivir | 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. | Day 30 post baseline | 
| Number of subjects with drug-resistant virus | Data on oseltamivir resistance are collected (as reported only) | Day 30 post-baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prospective, Observational Safety Study