Pandemic Influenza Clinical Trial
— PIPET BOfficial 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
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Status | Withdrawn |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 |
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.
Status | Withdrawn |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: |
Observational Model: Cohort, Time Perspective: Prospective
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 |
Lead Sponsor | Collaborator |
---|---|
Kirby Institute | National Health and Medical Research Council, Australia |
Australia,
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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