Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Intravenous Peramivir in Children With Influenza

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Influenza

In brief

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.

Key facts

Study ID

NCT01063933

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

0

Expected to finish

2012-12-01

Last updated by the study team

2011-11-11

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Children's Hospital of Orange County — Orange, California, United States
• Stanford University — Stanford, California, United States
• The Children's Hospital - Denver, Colorado — Denver, Colorado, United States
• Childrens National Medical Center — Washington D.C., District of Columbia, United States
• University of South Florida — Tampa, Florida, United States
• University of Louisville — Louisville, Kentucky, United States
• Tulane University — New Orleans, Louisiana, United States
• Louisiana State University — Shreveport, Louisiana, United States
• Boston Medical Center — Boston, Massachusetts, United States
• University of Massachusetts — Worcester, Massachusetts, United States
• Washington University in St. Louis — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• The Children's Hospital at Saint Peter's University Hospital — New Brunswick, New Jersey, United States
• North Shore-Long Island Jewish Health System — Manhasset, New York, United States
• NYU School of Medicine — New York, New York, United States
• New York Presbyterian Hospital-Weill Medical College of Cornell University — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• SUNY at Stony Brook — Stony Brook, New York, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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