Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Intravenous Peramivir in Children With Influenza
Status:
Withdrawn
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
The purposes of this study are to evaluate the pharmacokinetics (affect the body has on a
drug), and pharmacodynamics (affect the drug has on the body) and safety of an experimental
intravenous (within a vein) flu medication, peramivir, in children. Participants will include
63 hospitalized children with confirmed flu. Children will be grouped according to age and
younger children will not receive drug until safety data from the groups of older children
are reviewed. Hospitalized children may receive up to 5 doses of peramivir. Study procedures
include: nasal/throat swabs, reporting any experienced side effects, physical examination
including assessment of the nervous system, and blood sample collection. Participants will be
involved in study related procedures for up to 28 days.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)