A study of IV zanamivir in subjects with influenza

• Research type

  Research Study

• Full title

  An Open-Label, Multi-Center, Single Arm Study to Evaluate the Safety and Tolerability of Intravenous Zanamivir in the Treatment of Hospitalised Adult, Adolescent and Paediatric Subjects with Confirmed Influenza Infection

• IRAS ID

  33332

• Contact name

  Mervyn Singer

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2009-016035-35

• ISRCTN Number

  xx

• Research summary

  Pandemic flunza is considered to be the most significant public health threat caused by a naturally occurring pathogen. Pandemic flunza A (H1N1) 2009 has spread rapidly on a global scale, prompting the World Health Organisation (WHO) to raise the pandemic alert level to Phase 6 in June 2009. As of September 13, 2009, there have been over 296,000 documented cases of human infection with pandemic A (H1N1) 2009 virus worldwide, and over 3400 deaths. WHO have recently published guidelines for the pharmacological management of pandemic H1N1 2009 flunza and other flunza viruses which recommend that patients who have severe or progressive clinical illness should be treated with oseltamivir and that treatment should be initiated as soon as possible. This applies to all patient groups, including pregnant women, and young children less than 5 years old, including newborns. In situations where (1) oseltamivir is not available or not possible to use, or (2) if the virus is resistant to oseltamivir but known or likely to be susceptible to zanamivir, patients who have severe or progressive clinical illness should be treated with zanamivir. Of note, in developing the recommendations, the panel highlighted that further research is needed in the development of alternative formulations, including different routes of administration of zanamivir, particularly for use in severely ill patients.This is an open-label, single arm study to evaluate the safety and tolerability of IV zanamivir in patients hospitalised with confirmed flunza infection. The study duration is approximately 28 days for subjects whose treatment duration is 5 days. The initial treatment course may be extended for up to 5 additional days if further treatment with IV zanamivir is warranted. A single arm, open-label design has been selected to achieve the primary objective of providing regulatory authorities with safety data on IV zanamivir in an expedited manner.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  09/H0802/125

• Date of REC Opinion

  7 Dec 2009

• REC opinion

  Further Information Favourable Opinion