Influenza Clinical Trial
Official title:
Oseltamivir Treatment in Children Under One Year of Age With Moderate or Severe Influenza Lower Respiratory Tract Infection - a Clinical and Pharmacokinetic Study
Currently, there is no standard treatment for influenza with related lower respiratory tract infection (LRTI) in children younger than one year of age, even though influenza related LRTI is a potentially fatal illness in these children. This study will test a medicine for influenza in children younger than one year of age to see if it is safe and effective.
Influenza-related lower respiratory tract infection (LRTI) can cause serious illness or
death in children younger than a year old. Only four medications are registered to treat
influenza, and these do not have detailed recommendations for treating children younger than
one year of age. One of these medications, oseltamivir, has no official recommendation for
usage in children younger than one year of age, but it may be the best treatment for certain
strains of influenza. A small number of children younger than one year of age have received
oseltamivir in several countries with good clinical outcomes and apparently good
tolerability. This study will test oseltamivir in children younger than one year of age to
see if it is safe and effective.
Children younger than one year of age with influenza will be recruited for this study.
Participants will receive the usual care for influenza with the addition of oseltamivir.
Oseltamivir will be given orally for 5 days to children with human influenza, 7 days to
children with H1N1 influenza in Vietnam, and 10 days to children with avian influenza.
Participants will need to remain in the hospital between 5 and 12 days, depending on their
illnesses.
Study assessments will be performed daily for 14 days with follow-up examinations occurring
1 to 2 weeks, 6 months, and 12 months after study entry. These assessments will include
normal tests for children with influenza, such as blood tests and chest x-rays, but
additional blood and nose, throat, and mouth samples will be collected for the study.
Participants on a breathing machine will give lung samples.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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