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.
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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