Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000179336
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 antivirals in volunteers who receive short-term prophylaxis against pandemic influenza
Scientific title
A prospective study to examine the effectiveness and safety of antivirals in volunteers who receive short-term prophylaxis against pandemic influenza
Universal Trial Number (UTN)
Trial acronym
PIPET C
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pandemic influenza 2939 0
Condition category
Condition code
Infection 3078 3078 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 short-term prophylaxis against pandemic influenza infection in people who have close familial contact with the disease. The study is observational only.

The recommended adult dosage for oseltamavir for prophylaxis is 75mg once daily for ten days. Zanamivir prophylaxis consists of two 5mg doses (inhalations) once daily. Zanamivir can be either inhaled or is available intravenously. This protocol does not stipulate the dose or duration to be given to subjects, this will be determined by the treating physician and may differ to that normally indicated due to the pandemic environment. This study is observational only.
Intervention code [1] 2673 0
Not applicable
Comparator / control treatment
None - observational only
Control group
Historical

Outcomes
Primary outcome [1] 3963 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] 3963 0
One month
Secondary outcome [1] 6663 0
Seroconversion to pandemic influenza.
The participant is examined by a physician at each visit and all laboratory and adverse events are documented on an electronic case report form. At the end of the study the two drugs will be statistically compared to assess effectiveness in relation to seroconversion and adverse events.
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] 6663 0
One month
Secondary outcome [2] 6819 0
The incidence of adverse events.
The participant is examined by a physician at each visit and all laboratory and adverse events are documented on an electronic case report form. At the end of the study the two drugs will be statistically compared to assess effectiveness in relation to seroconversion and adverse events.
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] 6819 0
One month
Secondary outcome [3] 6820 0
The relative effectiveness of oseltamivir and zanamivir prophylaxis.
The participant is examined by a physician at each visit and all laboratory and adverse events are documented on an electronic case report form. At the end of the study the two drugs will be statistically compared to assess effectiveness in relation to seroconversion and adverse events.
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] 6820 0
One month

Eligibility
Key inclusion criteria
a) Provision of written informed consent
b) Intention to commence or have commenced short-term prophylaxis with a neuraminidase inhibitor in individuals who have been exposed to the pandemic virus
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
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3191 0
Government body
Name [1] 3191 0
National Health and Medical Research Council (NHMRC)
Country [1] 3191 0
Australia
Primary sponsor type
University
Name
National Centre in HIV Epidemiology and Clinical Research
Address
Level 2
376 Victoria Street
Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 2862 0
None
Name [1] 2862 0
Address [1] 2862 0
Country [1] 2862 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5177 0
St. Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 5177 0
Level 6
De Lacy Building
St Vincent's Hospital
Victoria Street
Darlinghurst NSW 2010
Ethics committee country [1] 5177 0
Australia
Date submitted for ethics approval [1] 5177 0
Approval date [1] 5177 0
17/12/2007
Ethics approval number [1] 5177 0
H06/119

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28448 0
Address 28448 0
Country 28448 0
Phone 28448 0
Fax 28448 0
Email 28448 0
Contact person for public queries
Name 11605 0
Allison Humphries
Address 11605 0
National Centre in HIV Epidemiology and Clinical Research (NCHECR)
Level 2
376 Victoria Street
Darlinghurst NSW 2010
Country 11605 0
Australia
Phone 11605 0
+61 2 9385 0900
Fax 11605 0
Email 11605 0
ahumphries@nchecr.unsw.edu.au
Contact person for scientific queries
Name 2533 0
Dr Dominic Dwyer
Address 2533 0
Department of Virology CIDMLS, ICPMR
Westmead Hospital
Level 3, Westmead Hospital
Hawkesbury Road
Westmead, NSW, 2145
Country 2533 0
Australia
Phone 2533 0
+61 2 9845 6694
Fax 2533 0
Email 2533 0
dominic_dwyer@wmi.usyd.edu.au

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.