IV Zanamivir versus ORal Oseltamivir for hospitalized influenza (ZORO)
Research type
Research Study
Full title
NAI114373: A Phase III international, randomized, doubleblind, double-dummy study to evaluate the efficacy and safety of 300 mg or 600 mg of intravenous zanamivir twice daily compared to 75 mg of oral oseltamivir twice daily in the treatment of hospitalized adults and adolescents with influenza.
IRAS ID
68201
Contact name
Adrian Bloor
Sponsor organisation
GlaxoSmithKline Research & Development Ltd
Eudract number
2010-021621-12
Clinicaltrials.gov Identifier
Research summary
flunza remains an important public health issue causing significant morbidity and mortality. Neuraminidase inhibitors are antiviral medicines that are known to be effective and well tolerated in the treatment and prevention of acute uncomplicated seasonal flunza and are available as inhaled zanamivir (Relenza?½) and oral oseltamivir (Taflu½). Patients with severe flunza may be unable to take medication orally or by inhalation. There is a need for an anti-viral treatment that can be given in a different way, such as directly into veins; this was highlighted during the pandemic of flunza A (HINI) in 2009.The purpose of this Phase III study is to obtain detailed information on how effective and safe intravenous (IV) zanamivir is compared to oral oseltamivir in adults and adolescents who are admitted to hospital with severe flunza infection. Approximately 10 patients will be recruited in the UK from 5 hospitals in Scotland/England. Patients will be randomly allocated either 300mg or 600mg of IV zanamivir or 75mg of oral oseltamivir. The study team and patient will be unaware which medication has been allocated. Treatment will be initially for 5 days and possibly for a further 5 days depending on their response to the treatment. The allocated treatment may be changed (switching to 600mg of IV zanamivir) between days 6 and 10 for up to an additional 5 days (maximum of 14 days of treatment) if the patient is not responding to their original treatment.Following treatment patients will be followed up for 28 days both in hospital and following discharge. During the study various samples will be taken (e.g. blood, nose swabs) and tests will be performed (e.g. ECG/cardiograph, vital signs). Information on other medicines the patient is taking and any unwanted side effects or other events experienced while taking part in the study will be recorded.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
10/H1003/120
Date of REC Opinion
14 Mar 2011
REC opinion
Further Information Favourable Opinion