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

NCT00640211 | Withdrawn

• 1 other identifier: PIPET B
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Pandemic Influenza

Keywords

Prophylaxis; pandemic influenza; influenza A; H5N1 virus

Outcome Measures

Primary Outcomes (1)

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

  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.

  One month

Study Arms (1)

PIPET B

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• none

Sponsors & Collaborators

• Kirby Institute: lead
• National Health and Medical Research Council, Australia: collaborator

Study Sites (8)

St Vincent's Hospital

Sydney, New South Wales, 2010, Australia

Location

Prince of Wales Hospital

Sydney, New South Wales, 2031, Australia

Location

Westmead Hospital

Sydney, New South Wales, 2145, Australia

Location

Royal Brisbane Hospital

Brisbane, Queensland, 4000, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Flinders Medical Centre

Adelaide, South Australia, 5042, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Study Officials

• Dominic Dwyer

  Westmead Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: March 17, 2008
• First Posted: March 21, 2008
• Last Updated: April 24, 2012

Record last verified: 2012-04

Locations

AU (8)