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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Status: Withdrawn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

Page last updated: August 23, 2015

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