Trial Review

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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/NCT00640302




Registration number
NCT00640302
Ethics application status
Date submitted
16/03/2008
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 Index Cases With Presumed Pandemic Influenza
Scientific title
A Prospective Study to Examine the Effectiveness and Safety of Neuraminidase Inhibitors in Index Cases With Presumed Pandemic Influenza Infection
Secondary ID [1] 0 0
PIPET A
Universal Trial Number (UTN)
Trial acronym
PIPET A
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 A - Patients presenting at study sites with the recognised clinical case definition for pandemic influenza (to be distributed by State and Commonwealth Departments of Health when first clinical case occurs) will be eligible to be enrolled on the study. Informed consent to participate in the study will be sought including parental/guardian consent for minors and presumed consent for adults who are incapacitated (consistent with NHMRC requirements).
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mortality
Timepoint [1] 0 0
One month

Eligibility
Key inclusion criteria
- Clinical diagnosis of pandemic influenza (consistent with the applicable clinical case
definition)

- Provision of written informed consent or equivalent

- Intention to commence treatment with a neuraminidase inhibitor
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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Withdrawn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
Flinders Medical Centre - Adelaide
Recruitment hospital [6] 0 0
Royal Adelaide Hospital - 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
3004 - Melbourne
Recruitment postcode(s) [7] 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 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
https://clinicaltrials.gov/ct2/show/NCT00640302
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dominic Dwyer, FRACP, FRCPA, MD
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

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

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/ct2/show/NCT00640302