This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.Over the past several years, there has been increasing activity of avian influenza in Pacific Rim countries, particularly Thailand, Vietnam, and Cambodia, as well as in the Netherlands and recently Africa, the Middle East, Turkey, Eastern Europe, France, Russia, and Indonesia. Unquestionably, avian influenza will spread to all countries of the world. The identification of influenza A (H5N1) and its associated pathogenicity in both poultry and humans has prompted concern worldwide for the potential of an influenza pandemic. Of note, Influenza A (H5N1) is associated with systemic illnesses, involving multiple organs (i.e. gastrointestinal tract and brain), in contrast to traditional influenza infections that tend to only involve the respiratory tract. Recent data indicate a preference for H5N1 replication in the lower respiratory tract rather than the upper airway. With further mutations, upper respiratory replication may well be enhanced, resulting in a greater probability of person to person transmission. Multi-organ involvement, the associated high mortality, and the potential for person to person transmission have all led public health officials worldwide, including the World Health Organization and Centers for Disease Control and Prevention, to consider the possibility of pandemic influenza with either this strain or a re-assortant.Infants and young children are at greatest risk of mortality from epidemic influenza,3-7 and children are disproportionately impacted by the H5N1 strains of influenza which are considered possible sources of the next influenza pandemic.Study objectives are:+ To define the pharmacokinetics of oseltamivir and oseltamivir carboxylate in children with confirmed influenza less than two years of age. These PK data will lead to a more precise dosing recommendation for this population. + To describe the frequency of all adverse events, including neurologic adverse events, among treated children+ To assess the clearance of virus and viral RNA (quantitative) as a function of drug pharmacokinetics+ To determine the potential for the development of resistance to oseltamivir as a function of pharmacokinetics and age (or cohort)
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