Protocol

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

Diseases

Infectious Diseases : Influenza

Description

Pandemic H1N1 2009 influenza infection has been characterized by typical influenza-like symptoms, including fever, cough, sore throat, body aches, headache, chills and fatigue;in addition, many people also have reported nausea, vomiting and/or diarrhea. Most patients to date have experienced relatively mild symptoms with full recovery. However, severe illness, and fatal infections have occurred more frequently in patients less than 25 years of age (particularly infants and children), in those with comorbidities, [Presence of more than one disease or health condition in an individual at a given time] and in pregnant women.

The purpose of this study is to test the safety of Zanamivir. Zanamivir (also known as Relenza™) is currently available in the market as an inhaler for treatment of the flu. This study is testing a new, intravenous (IV) form of this drug. This study will look at how people react to the study drug, and how the body uses the study drug.


Objectives

The goal of this study is to assess the safety and tolerability of IV zanamivir in the treatment of hospitalized adult, adolescent and pediatric subjects with influenza infection.


Eligibility

Patients who have severe or progressive flu illness on approved (fully licensed) medications used to treat the flu or who are considered unsuitable or inappropriate for treatment with approved flu medications.

For the current eligibility status of this clinical study and details of other study criteria, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE  (1-866-278-5833).


Contact

Aditya Gaur, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN  38105  USA
Voice: 1-866-2ST-JUDE (1-866-278-5833)
FAX: 901-595-5068

Referring or consulting physicians only: protocolinfo@stjude.org

For all other inquiries about St. Jude Children's Research Hospital studies: info@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.