PIPET C: A Prospective Study to Examine the Effectiveness and Safety of Antivirals in Volunteers Who Receive Short-term Prophylaxis Against Pandemic Influenza

Sponsor

Kirby Institute (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00640874

Collaborator

National Health and Medical Research Council, Australia (Other)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pandemic Influenza

Detailed Description

The aim of this study is to

Describe the effectiveness of short-term prophylaxis against symptomatic pandemic influenza infection
Describe the safety of short-term prophylaxis
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.

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Prospective Study to Examine the Effectiveness and Safety of Antivirals in Volunteers Who Receive Short-term Prophylaxis Against Pandemic Influenza.

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

The primary measure used in this study will be the incidence of symptomatic pandemic influenza in patients receiving prophylaxis. [One month]

Secondary Outcome Measures

Seroconversion to pandemic influenza, the incidence of adverse events and the relative effectiveness of oseltamivir and zanamivir prophylaxis will also be examined. [One month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St Vincent's Hospital	Sydney	New South Wales	Australia	2010
2	Prince of Wales Hospital	Sydney	New South Wales	Australia	2031
3	Westmead Hospital	Sydney	New South Wales	Australia	2145
4	Royal Brisbane Hospital	Brisbane	Queensland	Australia	4000
5	Royal Adelaide Hospital	Adelaide	South Australia	Australia	5000
6	Flinders Medical Centre	Adelaide	South Australia	Australia	5042
7	The Alfred Hospital	Melbourne	Victoria	Australia	3004
8	Royal Perth Hospital	Perth	Western Australia	Australia	6000