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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
National Health and Medical Research Council, Australia
Information provided by:
Kirby Institute
ClinicalTrials.gov Identifier:
NCT00640302
First received: March 16, 2008
Last updated: April 22, 2012
Last verified: April 2012
  Purpose

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.


Condition
Pandemic Influenza

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study to Examine the Effectiveness and Safety of Neuraminidase Inhibitors in Index Cases With Presumed Pandemic Influenza Infection

Resource links provided by NLM:


Further study details as provided by Kirby Institute:

Primary Outcome Measures:
  • Mortality [ Time Frame: One month ] [ Designated as safety issue: No ]

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.


Enrollment: 0
Groups/Cohorts
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).

Detailed Description:

The aim of this study is to describe treatment outcomes in patients infected with pandemic influenza (the most likely case being a version of the influenza A H5N1 virus) including overall survival, the incidence and duration of hospitalization, the resolution of protocol specified symptoms, the incidence and the severity of treatment limiting side effects in treated patients. This study will also describe the sequelae of influenza in infected patients including transmission to other persons, associations between baseline data and treatment outcomes and drug resistance. A repository of biological samples will also be created to examine virological and immunological concepts relating to pandemic influenza.

It is an open label prospective cohort study. 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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

Criteria

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

Exclusion Criteria:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00640302

Locations
Australia, New South Wales
St Vincent's Hospital
Sydney, New South Wales, Australia, 2010
Westmead Hospital
Sydney, New South Wales, Australia, 2145
Prince of Wales Hospital
Sydney, New South Wales, Australia, 2031
Australia, Queensland
Royal Brisbane Hospital
Brisbane, Queensland, Australia, 4000
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Flinders Medical Centre
Adelaide, South Australia, Australia, 5000
Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Sponsors and Collaborators
Kirby Institute
National Health and Medical Research Council, Australia
Investigators
Principal Investigator: Dominic Dwyer, FRACP, FRCPA, MD Westmead Hospital
  More Information

No publications provided

Responsible Party: Associate Professor Sean Emery, The National Centre in HIV Epidemiology and Clinical Research
ClinicalTrials.gov Identifier: NCT00640302     History of Changes
Other Study ID Numbers: PIPET A
Study First Received: March 16, 2008
Last Updated: April 22, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Kirby Institute:
Index cases
pandemic influenza
influenza A
H5N1 virus

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 23, 2014