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

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	Not yet recruiting
	Sydney, New South Wales, Australia, 2010
	Contact: Richard Norris 61 2 8382 2435 rnorris@stvincents.com.au
	Principal Investigator: David A Cooper
	Westmead Hospital	Not yet recruiting
	Sydney, New South Wales, Australia, 2145
	Contact: Margaret Piper +61 2 9845 6251 margaret_piper@wmi.usyd.edu.au
	Principal Investigator: Dominic Dwyer
	Prince of Wales Hospital	Not yet recruiting
	Sydney, New South Wales, Australia, 2031
	Contact: Suzanne Ryan 61 2 9382 3408 Suzanne.Ryan@SESIAHS.HEALTH.NSW.GOV.AU
	Principal Investigator: Kathleen Clezy

Australia, Queensland
	Royal Brisbane Hospital	Not yet recruiting
	Brisbane, Queensland, Australia, 4000
	Contact: Janelle Zillman +61 7 3636 7324 Janelle_Zillmann@health.qld.gov.au
	Principal Investigator: Anthony Allworth

Australia, South Australia
	Royal Adelaide Hospital	Not yet recruiting
	Adelaide, South Australia, Australia, 5000
	Contact: Lyndal Daly 61 8 8222 5635 ldaly@mail.rah.sa.gov.au
	Principal Investigator: David Shaw
	Flinders Medical Centre	Not yet recruiting
	Adelaide, South Australia, Australia, 5042
	Contact: Michelle Wall 61 8 8204 4292 Michelle.Wall@fmc.sa.gov.au
	Principal Investigator: David Gordon

Australia, Victoria
	The Alfred Hospital	Not yet recruiting
	Melbourne, Victoria, Australia, 3004
	Contact: Janine Roney 61 3 9076 6908 clinresearch@alfred.org.au
	Principal Investigator: Jennifer Hoy

Australia, Western Australia
	Royal Perth Hospital	Not yet recruiting
	Perth, Western Australia, Australia, 6000
	Contact: Claire Forsdyke 61 8 9224 3427 claire.forsdyke@health.wa.gov.au
	Principal Investigator: James Flexman

Sponsors and Collaborators

The National Centre in HIV Epidemiology and Clinical Research

National Health and Medical Research Council, Australia

Investigators


Principal Investigator:	Dominic Dwyer	Westmead Hospital

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
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

Orthomyxoviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections

ClinicalTrials.gov processed this record on October 17, 2008