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

Sponsor

Kirby Institute (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00640211

Collaborator

National Health and Medical Research Council, Australia (Other)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Pandemic Influenza

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.

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

The primary measure used in this study will be the incidence of symptomatic pandemic influenza in patients receiving prophylaxis. [One month]

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. [One month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	St Vincent's Hospital	Sydney	New South Wales	Australia	2010
2	Prince of Wales Hospital	Sydney	New South Wales	Australia	2031
3	Westmead Hospital	Sydney	New South Wales	Australia	2145
4	Royal Brisbane Hospital	Brisbane	Queensland	Australia	4000
5	Royal Adelaide Hospital	Adelaide	South Australia	Australia	5000
6	Flinders Medical Centre	Adelaide	South Australia	Australia	5042
7	The Alfred Hospital	Melbourne	Victoria	Australia	3004
8	Royal Perth Hospital	Perth	Western Australia	Australia	6000