IV zanamivir PK study in hospitalized infants with influenza infection
Research type
Research Study
Full title
An open label, single arm study to evaluate single and multiple dose pharmacokinetics, safety and tolerability, and to explore clinical outcomes of treatment with intravenous (IV) zanamivir in neonates and infants under 6 months of age with confirmed complicated influenza infection.
IRAS ID
287353
Contact name
Simon Nadel
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Ltd.
Eudract number
2019-001588-63
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
3 years, 1 months, 15 days
Research summary
Influenza infection continues to be an important public health priority, with seasonal outbreaks and pandemics causing considerable global morbidity and mortality. Between 3-11% of children aged <2 years in developed countries acquire influenza-associated illness every year, creating a major burden on both primary and secondary care services.
Antiviral treatment of neonates and infants under 6 months of age who are hospitalized with severe influenza infection remains a medical unmet need. Oral oseltamivir is currently the only treatment available for this age group but will not be suitable for all patients.
This study, funded by GlaxoSmithKline, will test an antiviral medicine called Zanamivir. Zanamivir is already licenced under the Trade name Relenza for the treatment of complicated and potentially life-threatening influenza A and B infection in over 6-month-old children and adults. It is used when other antiviral treatments are not suitable.Zanamivir works by blocking the action of neuraminidine, a protein produced by the virus that helps it to spread from infected cells to healthy cells. The purpose of this study is to see how the drug is affected in the body and to also look at any side effects from Zanamivir treatment in this population.
This study will enrol up to 16 participants. Each participant will receive up to 10 days of Zanamivir, one dose on Day 1 and two daily doses on Days 2-10, via a tube inserted into the vein. There will be a screening period, dosing for up to 10 days, and then follow up assessments 2, 7 and 14 days post-treatment.
Participants will undergo an eligibility assessment and have baseline measures taken including influenza and COVID-19 diagnostic tests, blood sample, nasopharyngeal swabs, physical exam and ECG. On study, participants will undergo daily clinical & safety assessments including blood draws (max. 5 samples) and regular nasopharyngeal swabs.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
20/YH/0268
Date of REC Opinion
23 Oct 2020
REC opinion
Further Information Favourable Opinion