A Prospective Study to Examine the Effectiveness and Safety of Antivirals in Volunteers Who Receive Short-term Prophylaxis Against Pandemic Influenza
PIPET C
1 other identifier
observational
N/A
1 country
8
Brief Summary
This aim of this project is to evaluate the efficacy of neuraminidase inhibitors as short-term prophylaxis against pandemic influenza infection in people who have close familial contact with the disease. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
8 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2008
CompletedFirst Posted
Study publicly available on registry
March 21, 2008
CompletedApril 24, 2012
April 1, 2012
March 17, 2008
April 22, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary measure used in this study will be the incidence of symptomatic pandemic influenza in patients receiving prophylaxis.
One month
Secondary Outcomes (1)
Seroconversion to pandemic influenza, the incidence of adverse events and the relative effectiveness of oseltamivir and zanamivir prophylaxis will also be examined.
One month
Study Arms (1)
PIPET C
Contact group members of people with diagnosed influenza who are recommended to receive NA inhibitor prophylaxis for short periods of time will be enrolled following provision of informed consent.
Eligibility Criteria
Contact group members of people with diagnosed influenza who are recommended to receive NA inhibitor prophylaxis for short periods of time will be enrolled following provision of informed consent. Each episode of short-term prophylaxis will be recorded separately.
You may qualify if:
- Provision of written informed consent
- Intention to commence or have commenced short-term prophylaxis with a neuraminidase inhibitor in individuals who have been exposed to the pandemic virus
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
St Vincent's Hospital
Sydney, New South Wales, 2010, Australia
Prince of Wales Hospital
Sydney, New South Wales, 2031, Australia
Westmead Hospital
Sydney, New South Wales, 2145, Australia
Royal Brisbane Hospital
Brisbane, Queensland, 4000, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Flinders Medical Centre
Adelaide, South Australia, 5042, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
Study Officials
- PRINCIPAL INVESTIGATOR
Dominic Dwyer
Westmead Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
March 17, 2008
First Posted
March 21, 2008
Last Updated
April 24, 2012
Record last verified: 2012-04