Clinical trial NCT00640211: A Prospective Study to Examine the Effectiveness and Safety of Neuraminidase Inhibitors in Volunteers Who Receive Long-term Prophylaxis Against Pandemic Influenza: 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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pandemic Influenza
Keywords: Prophylaxis
pandemic influenza
influenza A
H5N1 virus
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
Collaborators: name: National Health and Medical Research Council, Australia
First posted: 2008-03-21
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: The primary measure used in this study will be the incidence of symptomatic pandemic influenza in patients receiving prophylaxis.
timeFrame: One month
Secondary outcomes:
measure: Seroconversion to pandemic influenza, the incidence of adverse events and the relative effectiveness of oseltamivir and zanamivir prophylaxis will also be examined.
timeFrame: One month
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Brisbane Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Adelaide
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
Study officials:
affiliation: Westmead Hospital
name: Dominic Dwyer
role: PRINCIPAL_INVESTIGATOR
References: