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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00640211
Acronym
PIPET B
Enrollment
0
Registered
2008-03-21
Start date
Unknown
Completion date
Unknown
Last updated
2012-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pandemic Influenza

Keywords

Prophylaxis, pandemic influenza, influenza A, H5N1 virus

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.

Detailed 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.

Interventions

None listed

Sponsors

National Health and Medical Research Council, Australia
CollaboratorOTHER
Kirby Institute
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Seroconversion to pandemic influenza, the incidence of adverse events and the relative effectiveness of oseltamivir and zanamivir prophylaxis will also be examined.One month

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026