In This SectionTexas Health Research & Education Institute
Clinical Trials
Disease or Condition
Critical Care - Flu
Title
An Open-Label, Multi-Center, Single-Arm Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous Zanamivir in the Treatment of Hospitalized Adult, Adolescent and Pediatric Subjects with Confirmed Influenza Infection
Description
This study is to evaluate the safety and tolerability of IV zanamivir 600 mg twice daily for 5 days in hospitilized subjects with laboratory confirmed influenza infection.
IRB Number
Pro 1742
Inclusion/Notes
INCLUSION:
Hospitalized subjects with symptomatic influenza.
Subjects who have confirmed influenza as determined by a positive result in a rapid test for influenza A or influenza B, or a laboratory test for influenza including influenza virus antigen test, virus culture or RT-PCR test.
Subjects with negative rapid test result suspected of having influlenza can be enrolled following confirmatory testing by RT-PCR, antigen test or culture.
Subjects who are able to receive their first dose of study medication within seven days of experiencing influenza-like symptoms.
Subjects anticipated to require hospitalization for 5 or more days.
EXCLUSION:
Subjects who, in the opinion of the investigator, are not likely to survive the next 48 hours beyond Baseline.
Subjects who require concurrent therapy with another influenza antiviral drug.
Subjects who have participated in a study using an investigational influenza antiviral drug within 30 days prior to Baseline.
Subjects who are known or suspected to be hypersensitive to any component of the study medication.
Subjects who meet the following criteria at Baseline.
