NCT00640302|Withdrawn
A Prospective Study to Examine the Effectiveness and Safety of Neuraminidase Inhibitors in Index Cases With Presumed Pandemic Influenza
PIPET A
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PIPET A
Sponsor study identifier
observational
0
1 country
8
Study Start
Not reported
Date not reportedPrimary Completion
Not reported
Date not reportedStudy Completion
Not reported
Date not reportedThis 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 16, 2008
Actual (reported)March 21, 2008
Actual (reported)Mortality
One month
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).
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).
St Vincent's Hospital
Sydney, New South Wales, 2010, Australia
Prince of Wales Hospital
Sydney, New South Wales, 2031, Australia
Westmead Hospital
Sydney, New South Wales, 2145, Australia
Royal Brisbane Hospital
Brisbane, Queensland, 4000, Australia
Flinders Medical Centre
Adelaide, South Australia, 5000, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Patients will be asked to provide a blood sample and an appropriate respiratory tract sample. As a minimum, we will collect a combined nose and throat sample. A further respiratory tract swab will be collected on day 5 (range 5-10) and stored for future use. Index case follow-up will include an assessment and respiratory tract specimen and blood sample 14 days after informed consent. A final assessment for outcomes (including a blood sample) will occur approximately one month after enrolment.
Dominic Dwyer, FRACP, FRCPA, MD
Westmead Hospital
0 participants (actual enrollment reported by the registry).
First Submitted
March 16, 2008
First Posted
March 21, 2008
Last Updated
April 24, 2012
Record last verified: 2012-04
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Source: ClinicalTrials.gov.
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Royal Perth Hospital
Perth, Western Australia, 6000, Australia