NCT01527110

A Study of Intravenous Zanamivir in the Treatment of Hospitalized Patients With Influenza Infection

An Open-label, Multi-centre, Single Arm Study to Evaluate the Safety and Efficacy of Intravenous Zanamivir in the Treatment of Hospitalized Patients With Confirmed Influenza Infection (NAI115215)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

This study will be an open-label, multi-center, single arm study to evaluate the safety and efficacy of IV zanamivir 600mg twice daily for 5 days in hospitalized subjects with laboratory confirmed influenza infection.

Detailed description

Adult subjects and adolescent subjects (≥50 kg) with normal renal function will receive 600mg per dose. Subjects with renal impairment will receive an adjusted dose based on calculated creatinine clearance. The initial 5 day treatment course may be extended for up to 5 additional days if viral shedding is determined to be ongoing or if clinical symptoms warrant further treatment with IV zanamivir. The study duration is approximately 28 days for subjects whose treatment duration is 5 days, and up to approximately 33 days for subjects whose treatment duration is extended to a maximum of 10 days. The study will consist of Pre-dose Baseline Assessments (Day 1), During Treatment Assessments (Days 1 to 5, and up to Day 10), and Follow-up Assessments on the following days: Post-Treatment +2, +5, +9, +16 and +23 Days. For subjects who have been discharged from hospital, the Post-Treatment +2, +5, +9 and +16 Days Assessments can be made by telephone contact.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
DRUG	Intravenous (IV) zanamivir	Zanamivir aqueous solution 10mg/mL, 600mg of IV zanamivir infusion twice daily for 5 days

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-03-01
• Completion: 2013-03-29
• First posted: 2012-02-06
• Last updated: 2018-02-22
• Results posted: 2018-02-22

Locations

7 sites across 1 country: Japan