DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Kirby Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pandemic Influenza

Phase: N/A

Status: Withdrawn

Sponsored by: Kirby Institute

Official(s) and/or principal investigator(s):
Dominic Dwyer, Principal Investigator, Affiliation: Westmead Hospital

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.

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

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

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

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

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Prince of Wales Hospital, Sydney, New South Wales 2031, Australia

St Vincent's Hospital, Sydney, New South Wales 2010, Australia

Westmead Hospital, Sydney, New South Wales 2145, Australia

Royal Brisbane Hospital, Brisbane, Queensland 4000, Australia

Flinders Medical Centre, Adelaide, South Australia 5042, Australia

Royal Adelaide Hospital, Adelaide, South Australia 5000, Australia

The Alfred Hospital, Melbourne, Victoria 3004, Australia

Royal Perth Hospital, Perth, Western Australia 6000, Australia

Additional Information


Last updated: April 22, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017