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 infectio

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 3

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Area under the serum concentration-time curve (AUC)<br /><br>Maximum serum concentration (Cmax)<br /><br>Clearance (CL)<br /><br>Terminal half-life (t1/2)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Adverse events<br /><br>Vital signs including heart rate, oxygen saturation, respiration rate and<br /><br>temperature<br /><br>Quantitative viral load over time and change from baseline<br /><br>Viral susceptibility to zanamivir at baseline, and if virus can be cultured, at<br /><br>subsequent<br /><br>timepoints during the study<br /><br>Nucleotide sequence analysis to determine emergence of resistance to zanamivir</p><br>

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