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Available in the Gosset platform where reported.
01
Overview
Phase 2, open-label, single-arm trial of zanamivir in influenza, sponsored by GSK. Primary endpoints: Area under the serum concentration-time curve of zanamivir at Day 1, Maximum observed serum concentration of zanamivir at Day 1 and 2 more. Started Nov 2022; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Hospitalized neonates and infants with influenza infection
Participants receive daily IV infusion of zanamivir for up to 5-10 days.
03
Who it enrols
Hospitalized neonates and infants under 6 months of age (preterm >= 28 weeks PMA) with confirmed complicated influenza infection, weighing >= 1 kg, without severe liver dysfunction or concurrent anti-influenza therapy.
04
Endpoints
Primary
Area under the serum concentration-time curve of zanamivir
Maximum observed serum concentration of zanamivir
Clearance in plasma following administration of zanamivir
Terminal half-life of zanamivir
Secondary
Number of participants with adverse event(s) (AE) and serious adverse event(s) (SAE)
Number of participants with abnormal findings in heart rate
Number of participants with abnormal findings in Oxygen Saturation
Number of participants with abnormal findings in respiration rate
Number of participants with abnormal findings in body temperature
Viral load over time after administration of zanamivir
Change From Baseline in viral load after administration of zanamivir
Number of participants with phenotypic resistance
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Competitive context
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