Influenza Treatment with Zanamivir for Hospitalized Patients

Study to Evaluate the Safety and Tolerability of Intravenous Zanamivir in the Treatment of Hospitalized Adult, Adolescent and Pediatric Subjects with Confirmed Influenza Infection

Protocol Description

The purpose of this multi-center study is to evaluate the effects of treatment of influenza (flu) with zanamivir delivered intravenously rather than via traditional inhaler. Specifically, researchers will be monitoring the safety and tolerability of the medicine.

Study Level: Phase II

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to individuals of both genders ages six months through adult who are hospitalized with the flu.
Males: Ages 6 months through adult
Females: Ages 6 months through adult

Participants will be given intravenous dosages of zanamivir twice a day for 5 days and if needed, as determined by the patient’s doctor, for up to 10 days. Blood sampling will be done throughout the period in which the medicine is administered and electrocardiograms will be done at certain intervals. Patients will be recalled to the hospital for final tests following the study.
Visits: Requires hospitalization initially, then telephone follow-up and a visit after discharge
Duration: 4 to 5 weeks, inclusive of follow-up

Status: Enrolling hospitalized patients only

Source(s) of Support

Additional Information
Study description at National Institutes of Health

Primary Investigator(s)

Marian G. Michaels, MD, MPH

Contact Information

For information, or to enroll, please contact:
Diane Gwin RN, BSN, MSN, CCRC

Last Update
January 20, 2014
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Last Update
January 20, 2014