A Prospective Study to Examine the Effectiveness and Safety of Neuraminidase Inhibitors in Index Cases With Presumed Pandemic Influenza

NCT00640302 | Withdrawn

• 1 other identifier: PIPET A
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 8

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.

Conditions

Pandemic Influenza

Keywords

Index cases; pandemic influenza; influenza A; H5N1 virus

Outcome Measures

Primary Outcomes (1)

• Mortality

  One month

Study Arms (1)

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).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• 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

You may not qualify if:

• none

Sponsors & Collaborators

• Kirby Institute: lead
• National Health and Medical Research Council, Australia: collaborator

Study Sites (8)

St Vincent's Hospital

Sydney, New South Wales, 2010, Australia

Location

Prince of Wales Hospital

Sydney, New South Wales, 2031, Australia

Location

Westmead Hospital

Sydney, New South Wales, 2145, Australia

Location

Royal Brisbane Hospital

Brisbane, Queensland, 4000, Australia

Location

Flinders Medical Centre

Adelaide, South Australia, 5000, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Biospecimen

Retention: SAMPLES WITH DNA

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.

Study Officials

• Dominic Dwyer, FRACP, FRCPA, MD

  Westmead Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: March 16, 2008
• First Posted: March 21, 2008
• Last Updated: April 24, 2012

Record last verified: 2012-04

Locations

AU (8)