A Prospective Study to Examine the Effectiveness and Safety of Antivirals in Volunteers Who Receive Short-Term Prophylaxis Against Pandemic Influenza - Full Text View

Sponsors and Collaborators:	The National Centre in HIV Epidemiology and Clinical Research National Health and Medical Research Council, Australia
Information provided by:	The National Centre in HIV Epidemiology and Clinical Research
ClinicalTrials.gov Identifier:	NCT00640874

Purpose

This aim of this project is to evaluate the efficacy of neuraminidase inhibitors as short-term prophylaxis against pandemic influenza infection in people who have close familial contact with the disease. The study is observational only. The primary measure used in this study will be the incidence of symptomatic pandemic influenza in patients receiving prophylaxis. Seroconversion to pandemic influenza, the incidence of adverse events and the relative effectiveness of oseltamivir and zanamivir prophylaxis will also be examined. This project will commence upon pandemic influenza being declared in Australia, Hong Kong or Singapore. Data will be analysed as quickly as possible to help inform the continued use of neuraminidase inhibitor therapy as a cornerstone of the public health agency response to pandemic influenza.

Condition
Pandemic Influenza

MedlinePlus related topics: Flu

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	A Prospective Study to Examine the Effectiveness and Safety of Antivirals in Volunteers Who Receive Short-Term Prophylaxis Against Pandemic Influenza.

Further study details as provided by The National Centre in HIV Epidemiology and Clinical Research:

Primary Outcome Measures:

The primary measure used in this study will be the incidence of symptomatic pandemic influenza in patients receiving prophylaxis. [ Time Frame: One month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Seroconversion to pandemic influenza, the incidence of adverse events and the relative effectiveness of oseltamivir and zanamivir prophylaxis will also be examined. [ Time Frame: One month ] [ Designated as safety issue: No ]

Estimated Enrollment:

500

Groups/Cohorts
PIPET C Contact group members of people with diagnosed influenza who are recommended to receive NA inhibitor prophylaxis for short periods of time will be enrolled following provision of informed consent.

Detailed Description:

The aim of this study is to

Describe the effectiveness of short-term prophylaxis against symptomatic pandemic influenza infection
Describe the safety of short-term prophylaxis
Describe the seroconversion rate against pandemic influenza among recipients of short-term prophylaxis

The study is an open label prospective cohort study. Contact group members of people with diagnosed influenza who are recommended to receive NA inhibitor prophylaxis for short periods of time will be enrolled following provision of informed consent. Each episode of short-term prophylaxis will be recorded separately.

By design it is hoped that volunteers in this study who develop symptoms and signs of pandemic influenza infection will be enrolled in the Index Case (PIPET A) protocol with follow-up as required.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Contact group members of people with diagnosed influenza who are recommended to receive NA inhibitor prophylaxis for short periods of time will be enrolled following provision of informed consent. Each episode of short-term prophylaxis will be recorded separately.

Criteria

Inclusion Criteria:

Provision of written informed consent
Intention to commence or have commenced short-term prophylaxis with a neuraminidase inhibitor in individuals who have been exposed to the pandemic virus

Exclusion Criteria:

none

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640874

Locations

Australia, New South Wales
Prince of Wales Hospital
Sydney, New South Wales, Australia, 2031
St Vincent's Hospital
Sydney, New South Wales, Australia, 2010
Westmead Hospital
Sydney, New South Wales, Australia, 2145
Australia, Queensland
Royal Brisbane Hospital
Brisbane, Queensland, Australia, 4000
Australia, South Australia
Flinders Medical Centre
Adelaide, South Australia, Australia, 5042
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6000

Sponsors and Collaborators

The National Centre in HIV Epidemiology and Clinical Research

National Health and Medical Research Council, Australia

Investigators

Principal Investigator:

Dominic Dwyer

Sydney West Area Health Service

More Information

Responsible Party:	Therapeutic and Vaccine Research Program, National Centre in HIV Epidemiology and Clinical Research, University of New South Wales ( Sean Emery )
Study ID Numbers:	PIPET C
Study First Received:	March 17, 2008
Last Updated:	March 17, 2008
ClinicalTrials.gov Identifier:	NCT00640874
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by The National Centre in HIV Epidemiology and Clinical Research:

Prophylaxis
pandemic influenza
influenza A
H5N1 virus

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Influenza, Human
Influenza in Birds
Orthomyxoviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections

ClinicalTrials.gov processed this record on January 14, 2009