2014
DOI: 10.1093/ofid/ofu052.770
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1062Compassionate Use of Intravenous (IV) Zanamivir During the 2013-2014 Influenza Season: Case Series of Three Patients

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“…Despite its widespread use, there is a paucity of trials utilizing NAIs in hospitalized, critically ill, and immunocompromised patients. Occasionally non-FDA approved treatment options such as IV zanamivir will be released for compassionate use in these understudied populations (Shah et al, 2014), but outcomes data is not always adequately reported back to the pharmaceutical companies or FDA. Even when mortality and morbidity outcomes are available, the data could potentially suffer from selection bias given that they are usually administered to critically ill, and frequently moribund patients.…”
Section: Roundtable Discussionclinical Trial and Regulatory Issuesmentioning
confidence: 99%
“…Despite its widespread use, there is a paucity of trials utilizing NAIs in hospitalized, critically ill, and immunocompromised patients. Occasionally non-FDA approved treatment options such as IV zanamivir will be released for compassionate use in these understudied populations (Shah et al, 2014), but outcomes data is not always adequately reported back to the pharmaceutical companies or FDA. Even when mortality and morbidity outcomes are available, the data could potentially suffer from selection bias given that they are usually administered to critically ill, and frequently moribund patients.…”
Section: Roundtable Discussionclinical Trial and Regulatory Issuesmentioning
confidence: 99%