Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000178347
Ethics application status
Approved
Date submitted
18/03/2008
Date registered
9/04/2008
Date last updated
3/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public 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
Scientific 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
Universal Trial Number (UTN)
Trial acronym
PIPET B
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pandemic influenza 2938 0
Condition category
Condition code
Infection 3077 3077 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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 recommended adult dosage of oseltamivir for prophylaxis is 75mg once daily for seven days however safety and efficacy has been demonstrated for up to six weeks. Zanamivir prophylaxis consists of 2 x 5mg doses (inhalations) once daily. This study does not stipulate the dose or duration of the prophylaxis, this will be determined by the treating physician. Within the pandemic environment these listed doses or durations may be different. This study is observational only.
The Australian Pandemic Plan outlines that all "workers" at risk of pandemic influenza will be treated with prophylaxis. The workers at risk includes medical staff, border control and customs staff etc.
The duration of observation is 6 months.
Intervention code [1] 2672 0
Not applicable
Comparator / control treatment
None - observational only
Control group
Historical

Outcomes
Primary outcome [1] 3962 0
The incidence of symptomatic pandemic influenza in patients receiving prophylaxis.
All data will be collected on electronic case report forms. Data includes collection of laboratory and adverse event results to assess evidence of pandemic influenza.
Timepoint [1] 3962 0
One month
Secondary outcome [1] 6662 0
Seroconversion to pandemic influenza.
All data will be collected on electronic case report forms. Data includes collection of laboratory and adverse event results to assess evidence of pandemic influenza.
All (any) adverse events thought to be related to the NA inhibitor prophylaxis will be collected. These may include gastro-intestinal upsets, fatigue, sneezing, nausea, rash, basically any event that occurs post-prophylaxis that cannot be definitely ruled out as having a causal relationship.
Timepoint [1] 6662 0
One month
Secondary outcome [2] 6817 0
The incidence of adverse events
All data will be collected on electronic case report forms. Data includes collection of laboratory and adverse event results to assess evidence of pandemic influenza.
All (any) adverse events thought to be related to the NA inhibitor prophylaxis will be collected. These may include gastro-intestinal upsets, fatigue, sneezing, nausea, rash, basically any event that occurs post-prophylaxis that cannot be definitely ruled out as having a causal relationship.
Timepoint [2] 6817 0
One month
Secondary outcome [3] 6818 0
1. the relative effectiveness of oseltamivir and zanamivir prophylaxis.

2. Please specify how each of these outcomes will be measured i.e. what assessment tools/questionaires/tests will be used?
All data will be collected on electronic case report forms. Data includes collection of laboratory and adverse event results to assess evidence of pandemic influenza.
3. Please include examples of adverse effects that you will be measuring.
All (any) adverse events thought to be related to the NA inhibitor prophylaxis will be collected. These may include gastro-intestinal upsets, fatigue, sneezing, nausea, rash, basically any event that occurs post-prophylaxis that cannot be definitely ruled out as having a causal relationship.
Timepoint [3] 6818 0
One month

Eligibility
Key inclusion criteria
Inclusion criteria:
1. Provision of written informed consent
2. 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.
Minimum age
0 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3190 0
Government body
Name [1] 3190 0
National Health and Medical Research Council (NHMRC)
Country [1] 3190 0
Australia
Primary sponsor type
University
Name
National Centre in HIV Epidemiology and Clinical Research (NCHECR)
Address
Level 2
376 Victoria Street
Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 2861 0
None
Name [1] 2861 0
Address [1] 2861 0
Country [1] 2861 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5176 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 5176 0
Level 6
De Lacy Building
St Vincent's Hospital
Victoria Street
Darlinghurst NSW 2010
Ethics committee country [1] 5176 0
Australia
Date submitted for ethics approval [1] 5176 0
Approval date [1] 5176 0
17/12/2007
Ethics approval number [1] 5176 0
H06/118

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28447 0
Address 28447 0
Country 28447 0
Phone 28447 0
Fax 28447 0
Email 28447 0
Contact person for public queries
Name 11604 0
Allison Humphries
Address 11604 0
National Centre in HIV Epidemiology and Clinical Research (NCHECR)
Level 2
376 Victoria Street
Darlinghurst NSW 2010
Country 11604 0
Australia
Phone 11604 0
61 2 9385 0900
Fax 11604 0
Email 11604 0
[email protected]
Contact person for scientific queries
Name 2532 0
Dr Dominic Dwyer
Address 2532 0
Department of Virology CIDMLS, ICPMR
Westmead Hospital
Level 3, Westmead Hospital
Hawkesbury Road
Westmead, NSW, 2145
Country 2532 0
Australia
Phone 2532 0
+61 2 9845 6694
Fax 2532 0
Email 2532 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.