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NCT00640211 Clinical Trial

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

Pandemic Influenza Clinical Trial

— PIPET B  

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00640211
Other study ID # PIPET B
Secondary ID
Status Withdrawn
Phase N/A
First received March 17, 2008
Last updated April 22, 2012

Study information
Verified date April 2012
Source Kirby Institute
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods Administration
Study type Observational

Clinical Trial 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.

Description:

The aim of this study is to

1. 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

2. Describe the incidence of seroconversion to pandemic influenza

3. Describe the incidence of adverse events in volunteers taking long term antiviral prophylaxis

4. 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility 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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Australia Flinders Medical Centre Adelaide South Australia
Australia Royal Adelaide Hospital Adelaide South Australia
Australia Royal Brisbane Hospital Brisbane Queensland
Australia The Alfred Hospital Melbourne Victoria
Australia Royal Perth Hospital Perth Western Australia
Australia Prince of Wales Hospital Sydney New South Wales
Australia St Vincent's Hospital Sydney New South Wales
Australia Westmead Hospital Sydney New South Wales

Sponsors (2)
Lead Sponsor Collaborator
Kirby Institute National Health and Medical Research Council, Australia

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary The primary measure used in this study will be the incidence of symptomatic pandemic influenza in patients receiving prophylaxis. One month No
Secondary Seroconversion to pandemic influenza, the incidence of adverse events and the relative effectiveness of oseltamivir and zanamivir prophylaxis will also be examined. One month No
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Withdrawn NCT00640302 - A Prospective Study to Examine the Effectiveness and Safety of Neuraminidase Inhibitors in Index Cases With Presumed Pandemic Influenza N/A
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