A Prospective Study to Examine the Effectiveness and Safety of Neuraminidase Inhibitors in Volunteers Who Receive Long-Term Prophylaxis Against Pandemic Influenza: PIPET B

This study is not yet open for participant recruitment.

Verified by The National Centre in HIV Epidemiology and Clinical Research, March 2008

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:	NCT00640211

Purpose

This aim of this project is to evaluate the efficacy of neuraminidase inhibitors as prophylaxis against pandemic influenza infection in patients who are prescribed a long term course in the context of a place of employment or profession. 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 Neuraminidase Inhibitors in Volunteers Who Receive Long-Term Prophylaxis Against Pandemic Influenza: PIPET B

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 ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Estimated Enrollment:

1000

Groups/Cohorts
PIPET B Participants in this study will be health care and other essential workers receiving long term neuraminidase inhibitor prophylaxis.

Detailed Description:

The aim of this study is to

Describe the incidence of symptomatic pandemic influenza infection in participants receiving neuraminidase inhibitor prophylaxis in the context of a place of employment or a profession
Describe the incidence of seroconversion to pandemic influenza
Describe the incidence of adverse events in volunteers taking long term antiviral prophylaxis
Compare the effectiveness of oseltamivir and zanamivir prophylaxis

The study is an open label prospective cohort study. Participants in this study will be health care and other essential workers receiving long term neuraminidase inhibitor prophylaxis.

Eligibility

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

Study Population

Participants in this study will be health care and other essential workers receiving long term neuraminidase inhibitor prophylaxis.

Criteria

Inclusion Criteria:

Provision of written informed consent
Intention to commence, or already commenced prophylaxis with a neuraminidase inhibitor in the context of a place of employment or profession

It is anticipated that participants in this study who are subsequently clinically diagnosed with pandemic influenza will be enrolled in the Index Case protocol (PIPET-A) with follow-up as specified.

Exclusion Criteria:

none

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640211

Contacts

Contact: Allison Humphries	+61 2 9385 0900	ahumphries@nchecr.unsw.edu.au
Contact: Sean Emery	+61 2 9385 0900	semery@nchecr.unsw.edu.au

Locations

Australia, New South Wales
St Vincent's Hospital
Sydney, New South Wales, Australia, 2010
Westmead Hospital
Sydney, New South Wales, Australia, 2145
Prince of Wales Hospital
Sydney, New South Wales, Australia, 2031
Australia, Queensland
Royal Brisbane Hospital
Brisbane, Queensland, Australia, 4000
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Flinders Medical Centre
Adelaide, South Australia, Australia, 5042
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 Programme, National Centre in HIV Epidemiology and Clinical Research, University of New South Wales ( Associate Professor Sean Emery )
Study ID Numbers:	PIPET B
Study First Received:	March 17, 2008
Last Updated:	March 17, 2008
ClinicalTrials.gov Identifier:	NCT00640211
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