Influenza
Conditions
Interventions
The initial dose of IV zanamivir will be determined by PMA/corrected age and
bodyweight. The maintenance dose and interval between the initial dose and
subsequent twice-daily maintenance dose will b
Sponsors
GlaxoSmithKline
Eligibility
Age
No minimum to 1 Years
Inclusion criteria
Inclusion criteria: 1. Neonates and infants who are aged less than 6 months (corrected age). Preterm neonates and infants will be eligible for inclusion but must have reached Post-Menstrual Age (PMA) of at least 28 weeks 2. Participants who are hospitalised with influenza infection. 3.Participants with a high risk of altered oral drug absorption, represented by multi-organ dysfunction (dysfunction of at least 2 organs, as defined by the treating physician). 4. Body weight >=1kg
Exclusion criteria
Exclusion criteria: 1. Participants who are known or suspected to be hypersensitive to any component of the study medication. 2. Participants with a disease process which is likely to be irreversible. 3. Liver function: Subjects who meet the following criteria at Baseline: ALT >=3xULN with Bilirubin >=2xULN, or Isolated bilirubin >= 2xULN and >50% direct bilirubin, or ALT >=5xULN Current or chronic history of liver disease or known hepatic or biliary abnormalities. 4. Participants who require concurrent therapy with another influenza antiviral drug. 5. Participants who have participated in a study using an investigational drug within 30 days prior to Baseline. 6. Child in care (CiC), as defined below: • A child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. • The definition of a CiC can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a CiC does not include a child who is adopted or has an appointed legal guardian. 7. Patients undergoing treatment by Extracorporeal membrane oxygenation (ECMO) or hemofiltration. 8. Participants who are positive for SARS-CoV-2, as determined by a diagnostic test, at screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the serum concentration-time curve (AUC) Maximum serum concentration (Cmax) Clearance (CL) Terminal half-life (t1/2) | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events Vital signs including heart rate, oxygen saturation, respiration rate and temperature Quantitative viral load over time and change from baseline Viral susceptibility to zanamivir at baseline, and if virus can be cultured, at subsequent timepoints during the study Nucleotide sequence analysis to determine emergence of resistance to zanamivir | — |
Countries
Netherlands
Outcome results
None listed