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A Prospective Study to Examine the Effectiveness and Safety of Neuraminidase Inhibitors in Volunteers Who Receive Long-term Prophylaxis Against Pandemic Influenza: PIPET B

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
National Health and Medical Research Council, Australia
Information provided by:
Kirby Institute
ClinicalTrials.gov Identifier:
NCT00640211
First received: March 17, 2008
Last updated: April 22, 2012
Last verified: April 2012
History of Changes
  Purpose

This aim of this project is to evaluate the efficacy of neuraminidase inhibitors as prophylaxis against pandemic influenza infection in patients who are prescribed a long term course in the context of a place of employment or profession. 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
Pandemic Influenza

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study to Examine the Effectiveness and Safety of Neuraminidase Inhibitors in Volunteers Who Receive Long-term Prophylaxis Against Pandemic Influenza: PIPET B

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Kirby Institute:

Primary Outcome Measures:
  • The primary measure used in this study will be the incidence of symptomatic pandemic influenza in patients receiving prophylaxis. [ Time Frame: One month ] [ Designated as safety issue: No ]

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. [ Time Frame: One month ] [ Designated as safety issue: No ]

Enrollment: 0
Groups/Cohorts
PIPET B
Participants in this study will be health care and other essential workers receiving long term neuraminidase inhibitor prophylaxis.

Detailed Description:

The aim of this study is to

  1. Describe the incidence of symptomatic pandemic influenza infection in participants receiving neuraminidase inhibitor prophylaxis in the context of a place of employment or a profession
  2. Describe the incidence of seroconversion to pandemic influenza
  3. Describe the incidence of adverse events in volunteers taking long term antiviral prophylaxis
  4. Compare the effectiveness of oseltamivir and zanamivir prophylaxis

The study is an open label prospective cohort study. Participants in this study will be health care and other essential workers receiving long term neuraminidase inhibitor prophylaxis.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Participants in this study will be health care and other essential workers receiving long term neuraminidase inhibitor prophylaxis.

Criteria

Inclusion Criteria:

  • Provision of written informed consent
  • Intention to commence, or already commenced prophylaxis with a neuraminidase inhibitor in the context of a place of employment or profession

It is anticipated that participants in this study who are subsequently clinically diagnosed with pandemic influenza will be enrolled in the Index Case protocol (PIPET-A) with follow-up as specified.

Exclusion Criteria:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00640211

Locations
Australia, New South Wales
St Vincent's Hospital
Sydney, New South Wales, Australia, 2010
Westmead Hospital
Sydney, New South Wales, Australia, 2145
Prince of Wales Hospital
Sydney, New South Wales, Australia, 2031
Australia, Queensland
Royal Brisbane Hospital
Brisbane, Queensland, Australia, 4000
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Flinders Medical Centre
Adelaide, South Australia, Australia, 5042
Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Sponsors and Collaborators
Kirby Institute
National Health and Medical Research Council, Australia
Investigators
Principal Investigator: Dominic Dwyer Westmead Hospital
  More Information

No publications provided

Responsible Party: Associate Professor Sean Emery, Therapeutic and Vaccine Research Programme, National Centre in HIV Epidemiology and Clinical Research, University of New South Wales
ClinicalTrials.gov Identifier: NCT00640211     History of Changes
Other Study ID Numbers: PIPET B
Study First Received: March 17, 2008
Last Updated: April 22, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Kirby Institute:
Prophylaxis
pandemic influenza
influenza A
H5N1 virus

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013