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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: 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.

• Study Type: Observational

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2145
      • Westmead Hospital
    • Sydney, New South Wales, Australia, 2010
      • St Vincent'S Hospital
    • Sydney, New South Wales, Australia, 2031
      • Prince of Wales Hospital
  • Queensland
    • Brisbane, Queensland, Australia, 4000
      • Royal Brisbane Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
    • Adelaide, South Australia, Australia, 5042
      • Flinders Medical Centre
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital
  • Western Australia
    • Perth, Western Australia, Australia, 6000
      • Royal Perth Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary measure used in this study will be the incidence of symptomatic pandemic influenza in patients receiving prophylaxis.	One month

Secondary Outcome Measures

Outcome Measure	Time Frame
Seroconversion to pandemic influenza, the incidence of adverse events and the relative effectiveness of oseltamivir and zanamivir prophylaxis will also be examined.	One month

Collaborators and Investigators

• Sponsor: Kirby Institute
• Collaborators: National Health and Medical Research Council, Australia
• Investigators: Principal Investigator: Dominic Dwyer, Westmead Hospital

Study record dates

Study Registration Dates

• First Submitted: March 17, 2008
• First Submitted That Met QC Criteria: March 17, 2008
• First Posted (Estimate): March 21, 2008

Study Record Updates

• Last Update Posted (Estimate): April 24, 2012
• Last Update Submitted That Met QC Criteria: April 22, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Prophylaxis; pandemic influenza; influenza A; H5N1 virus
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: PIPET C