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WithdrawnNCT00640874PIPET CUpdated Apr 24, 2012

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

An observational study in Pandemic Influenza, sponsored by Kirby Institute. Withdrawn at 8 sites in Australia. Per ClinicalTrials.gov, last updated 2012-04-24.

Sponsored by Kirby Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pandemic Influenza

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Keywords

  • Prophylaxis
  • pandemic influenza
  • influenza A
  • H5N1 virus
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

Browse Influenza, Human studies →

Lead sponsor

Kirby Institute is the lead sponsor of 94 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

Exclusion Criteria:

  • none
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. The primary measure used in this study will be the incidence of symptomatic pandemic influenza in patients receiving prophylaxis.

    Time frame: One month

Secondary outcomes

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

    Time frame: One month

07

Study locations

8 sites
  • St Vincent's Hospital
    Sydney, New South Wales 2010, Australia
  • Prince of Wales Hospital
    Sydney, New South Wales 2031, Australia
  • Westmead Hospital
    Sydney, New South Wales 2145, Australia
  • Royal Brisbane Hospital
    Brisbane, Queensland 4000, Australia
  • Royal Adelaide Hospital
    Adelaide, South Australia 5000, Australia
  • Flinders Medical Centre
    Adelaide, South Australia 5042, Australia
  • The Alfred Hospital
    Melbourne, Victoria 3004, Australia
  • Royal Perth Hospital
    Perth, Western Australia 6000, Australia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00640874
Lead sponsor
Kirby Institute
Collaborators
National Health and Medical Research Council, Australia
First posted
Mar 21, 2008
Last update
Apr 24, 2012

Study contacts

Dominic Dwyer
principal investigator · Westmead Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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