A Prospective Study to Examine the Effectiveness and Safety of Antivirals in Volunteers Who Receive Short-term Prophylaxis Against Pandemic Influenza
Information source: Kirby Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pandemic Influenza
Phase: N/A
Status: Withdrawn
Sponsored by: Kirby Institute Official(s) and/or principal investigator(s): Dominic Dwyer, Principal Investigator, Affiliation: Westmead Hospital
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.
Clinical Details
Official title: A Prospective Study to Examine the Effectiveness and Safety of Antivirals in Volunteers Who Receive Short-term Prophylaxis Against Pandemic Influenza.
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: The primary measure used in this study will be the incidence of symptomatic pandemic influenza in patients receiving prophylaxis.
Secondary outcome: Seroconversion to pandemic influenza, the incidence of adverse events and the relative effectiveness of oseltamivir and zanamivir prophylaxis will also be examined.
Detailed description:
The aim of this study is to
1. Describe the effectiveness of short-term prophylaxis against symptomatic pandemic
influenza infection
2. Describe the safety of short-term prophylaxis
3. Describe the seroconversion rate against pandemic influenza among recipients of
short-term prophylaxis
The study is an open label prospective cohort study. 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.
By design it is hoped that volunteers in this study who develop symptoms and signs of
pandemic influenza infection will be enrolled in the Index Case (PIPET A) protocol with
follow-up as required.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- none
Locations and Contacts
Prince of Wales Hospital, Sydney, New South Wales 2031, Australia
St Vincent's Hospital, Sydney, New South Wales 2010, Australia
Westmead Hospital, Sydney, New South Wales 2145, Australia
Royal Brisbane Hospital, Brisbane, Queensland 4000, Australia
Flinders Medical Centre, Adelaide, South Australia 5042, Australia
Royal Adelaide Hospital, Adelaide, South Australia 5000, Australia
The Alfred Hospital, Melbourne, Victoria 3004, Australia
Royal Perth Hospital, Perth, Western Australia 6000, Australia
Additional Information
Last updated: April 22, 2012
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