Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000176369
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 index cases with presumed pandemic influenza infection
Scientific title
A prospective study to examine the effectiveness and safety of neuraminidase inhibitors in index cases with presumed pandemic influenza infection
Universal Trial Number (UTN)
Trial acronym
PIPET A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pandemic influenza 2937 0
Condition category
Condition code
Infection 3076 3076 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 in patients who have a clinical diagnosis of pandemic influenza infection. The study is observational only.
Recommended dosage of oseltamivir is 75mg orally (capsules) twice daily for five days, starting within 48 hours of symptom onset. Children greater than one year old may be administered a suspension in the following dosages: less than or equal to 15kg to take 30mg twice daily; 15-23kg 45mg twice daily; 23-40kg 60mg twice daily and over 40kg 75mg twice daily. Zanamivir is administered via inhalation and comes in a breath-activated plastic device (diskhaler). The recommended adult dosage of zanamivir is 10mg (2x5mg inhalations) twice daily for five days. Zanamivir is not generally recommended in children less then 5 years old. This study does not stipulate the dose or duration of these drugs, this is to be determined by the treating physician. In the environment of a pandemic the dose and or duration may differ. This is an observational study only.
The duration of the observation is one month.
Intervention code [1] 2758 0
Not applicable
Comparator / control treatment
Observational
Control group
Historical

Outcomes
Primary outcome [1] 3961 0
Mortality
Timepoint [1] 3961 0
One month
Secondary outcome [1] 6661 0
Symptom severity and duration. The participant is examined by a physician at each visit and all laboratory and adverse events are documented on an electronic case report form.
Timepoint [1] 6661 0
One month
Secondary outcome [2] 6815 0
Treatment limiting side effects
Timepoint [2] 6815 0
One month
Secondary outcome [3] 6816 0
Demographic information and resistance.
Timepoint [3] 6816 0
One month

Eligibility
Key inclusion criteria
1. Clinical diagnosis of pandemic influenza (consistent with the applicable clinical case definition)
2. Provision of written informed consent or equivalent
3. Intention to commence treatment with a neuraminidase inhibitor
Minimum age
0 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
There are no exclusion criteria.

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] 3189 0
Government body
Name [1] 3189 0
National Health and Medical Research Council (NHMRC)
Country [1] 3189 0
Australia
Primary sponsor type
University
Name
National Centre in HIV Epidemiology and Clinical Research (NCHECR)
Address
Level 2
376 Victoria Street
Darlinghurst NSW
Country
Australia
Secondary sponsor category [1] 2860 0
None
Name [1] 2860 0
Address [1] 2860 0
Country [1] 2860 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5175 0
St. Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 5175 0
Level 6
De Lacy Building
St. Vincent's Hospital
Victoria Street
Darlinghurst NSW 2010
Ethics committee country [1] 5175 0
Australia
Date submitted for ethics approval [1] 5175 0
Approval date [1] 5175 0
17/12/2007
Ethics approval number [1] 5175 0
H06/117

Summary
Brief summary
This aim of this project is to evaluate the efficacy of neuraminidase inhibitors in patients who have a clinical diagnosis of pandemic influenza infection. The study is observational only. The primary measure used in this study will be mortality. Symptom severity and duration, treatment limiting side effects, demographic information and resistance 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 28446 0
Address 28446 0
Country 28446 0
Phone 28446 0
Fax 28446 0
Email 28446 0
Contact person for public queries
Name 11603 0
Allison Humphries
Address 11603 0
National Centre in HIV Epidemiology and Clinical Research (NCHECR)
Level 2
376 Victoria Street
Darlinghurst NSW
Country 11603 0
Australia
Phone 11603 0
61 2 9385 0900
Fax 11603 0
Email 11603 0
[email protected]
Contact person for scientific queries
Name 2531 0
Dr Dominic Dwyer
Address 2531 0
Department of Virology CIDMLS, ICPMR
Westmead Hospital
Level 3, Westmead Hospital
Hawkesbury Road
Westmead, NSW, 2145
Country 2531 0
Australia
Phone 2531 0
+61 2 9845 6694
Fax 2531 0
Email 2531 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.