The purpose of this study is to determine whether zanamivir aqueous solution given by intravenous injection is safe in treating hospitalized patients with confirmed influenza infection. A single arm open-label design has been selected to achieve the primary objective of providing regulatory authorities with safety data on IV zanamivir.
Age range
6 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of Participants With Any Adverse Event (AE) Considered to be Related to Study Treatment
Timeframe: Up to post-treatment (PT) + 23 days
Number of Participants With Any Severe or Grade 3/4 AEs
Timeframe: Up to post-treatment (PT) + 23 days
Number of Participants With Any Severe or Grade 3/4 Treatment-related AE
Timeframe: Up to post-treatment (PT) + 23 days
Number of Participants Who Permanently Discontinued the Study Treatment Due to an AE
Timeframe: Up to 10 days
Number of Participants Who Were Permanently Discontinued From the Study Due to an AE
Timeframe: Up to post-treatment (PT) + 23 days
Number of Participants With the Indicated Clinical Chemistry Values Relative to the Normal Range at Baseline (Day 1) and Day 5
Timeframe: Baseline (Day 1) and Day 5
Number of Participants With the Indicated Hematology Values Relative to the Normal Range at Baseline (Day 1) and Day 5
Timeframe: Baseline (Day 1) and Day 5
Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Toxicities
Timeframe: Up to post-treatment (PT) + 23 days
Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Hematology Toxicities
Timeframe: Up to post-treatment (PT) + 23 days
Median Heart Rate at Baseline (Day 1) and Day 5
Timeframe: Baseline (Day 1) and Day 5
Median Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline (Day 1) and Day 5
Timeframe: Baseline (Day 1) and Day 5
Median Oxygen Saturation Measured Via Transcutaneous Oximetry (TCPO2) at Baseline (Day 1) and Day 5
Timeframe: Baseline (Day 1) and Day 5
Median Respiration Rate at Baseline (Day 1) and Day 5
Timeframe: Baseline (Day 1) and Day 5
Median Body Temperature at Baseline (Day 1) and Day 5
Timeframe: Baseline (Day 1) and Day 5
Number of Participants Assessed as Normal/Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at Baseline (Day 1)
Timeframe: Baseline (Day 1)
Median Corrected QT Interval (QTc) for Heart Rate by Fridericia's Formula (QTcF) and Bazett's Formula (QTcB) at Baseline (Day 1) and Day 5
Timeframe: Baseline (Day 1) and Day 5