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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00640211




Registration number
NCT00640211
Ethics application status
Date submitted
17/03/2008
Date registered
21/03/2008
Date last updated
24/04/2012

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
Secondary ID [1] 0 0
PIPET B
Universal Trial Number (UTN)
Trial acronym
PIPET B
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pandemic Influenza 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
PIPET B - Participants in this study will be health care and other essential workers receiving long term neuraminidase inhibitor prophylaxis.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary measure used in this study will be the incidence of symptomatic pandemic influenza in patients receiving prophylaxis.
Timepoint [1] 0 0
One month
Secondary outcome [1] 0 0
Seroconversion to pandemic influenza, the incidence of adverse events and the relative effectiveness of oseltamivir and zanamivir prophylaxis will also be examined.
Timepoint [1] 0 0
One month

Eligibility
Key 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.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- none

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
St Vincent's Hospital - Sydney
Recruitment hospital [2] 0 0
Prince of Wales Hospital - Sydney
Recruitment hospital [3] 0 0
Westmead Hospital - Sydney
Recruitment hospital [4] 0 0
Royal Brisbane Hospital - Brisbane
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [7] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [8] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
2031 - Sydney
Recruitment postcode(s) [3] 0 0
2145 - Sydney
Recruitment postcode(s) [4] 0 0
4000 - Brisbane
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
5042 - Adelaide
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment postcode(s) [8] 0 0
6000 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
Kirby Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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
https://clinicaltrials.gov/ct2/show/NCT00640211
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dominic Dwyer
Address 0 0
Westmead Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00640211