NCT01231620

A Study of Intravenous Zanamivir Versus Oral Oseltamivir in Adults and Adolescents Hospitalized With Influenza

A Phase III International, Randomized, Double-blind, Double-dummy Study to Evaluate the Efficacy and Safety of 300 mg or 600 mg of Intravenous Zanamivir Twice Daily Compared to 75 mg of Oral Oseltamivir Twice Daily in the Treatment of Hospitalized Adults and Adolescents With Influenza

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 626 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the safety and efficacy of zanamivir given intravenously and how well it works at two different doses in hospitalized adolescents and adults with flu. Zanamivir will be compared with oseltamivir, which is used for treating flu.

Detailed description

The recent influenza pandemic has highlighted the need for alternative formulations for anti-influenza therapies. This will be an international Phase III, double-blind, double-dummy, 3-arm study to evaluate the efficacy, antiviral activity and safety of IV zanamivir 600 mg twice daily compared to oral oseltamivir 75 mg twice daily, and 600 mg IV zanamivir twice daily compared to 300 mg IV zanamivir for 5 days in hospitalized subjects with laboratory confirmed or suspected influenza infection. For a given subject, the initial 5-day treatment course may be extended for up to 5 additional days if clinical symptoms or patient characteristics as assessed by the investigator warrant further treatment. Alternatively, if the investigator considers that a subject is failing to improve clinically on their randomized treatment, the investigator can choose to initiate the switch/rescue option (600 mg IV zanamivir twice daily) on any day from Day 6 through Day 10 for up to an additional 5 days of treatment. On switching treatments, subjects complete a maximum of 14 days of treatment and are followed-up to Post-Treatment +28 Days.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
DRUG	Zanamivir	Zanamivir aqueous solution, 10 mg/mL, will be provided as a single use, sterile clear, colorless preparation in 20 mL clear glass vials.
DRUG	Placebo to match zanamivir	Placebo to match IV zanamivir will be provided as a normal saline solution of a matched volume.
DRUG	Oseltamivir	Oseltamivir will be provided as over-encapsulated 75 mg capsules.
DRUG	Placebo to match oseltamivir	Placebo to match oral oseltamivir will be provided as capsules with a common excipient of appropriate quality.

Timeline

• Start date: 2011-01-15
• Primary completion: 2015-03-18
• Completion: 2015-03-18
• First posted: 2010-11-01
• Last updated: 2018-10-15
• Results posted: 2017-11-20

Locations

170 sites across 28 countries: United States, Australia, Belgium, Brazil, Canada, China, Colombia, Czechia, Denmark, France, Germany, Greece, Hong Kong, Hungary, India, Mexico, Netherlands, New Zealand, Norway, Poland, Russia, Slovakia, South Africa, South Korea, Spain, Taiwan, Thailand, United Kingdom