Clinical trial NCT00640874: A Prospective Study to Examine the Effectiveness and Safety of Antivirals in Volunteers Who Receive Short-term Prophylaxis Against Pandemic Influenza
Official title: A Prospective Study to Examine the Effectiveness and Safety of Antivirals in Volunteers Who Receive Short-term Prophylaxis Against Pandemic Influenza.
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Overall status: WITHDRAWN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: 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.

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.

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 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

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: