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

Sponsor

Kirby Institute (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00640302

Collaborator

National Health and Medical Research Council, Australia (Other)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pandemic Influenza

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).

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

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

Arms and Interventions

Arm	Intervention/Treatment
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).

Arm

Intervention/Treatment

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).

Outcome Measures

Primary Outcome Measures

Mortality [One month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	St Vincent's Hospital	Sydney	New South Wales	Australia	2010
2	Prince of Wales Hospital	Sydney	New South Wales	Australia	2031
3	Westmead Hospital	Sydney	New South Wales	Australia	2145
4	Royal Brisbane Hospital	Brisbane	Queensland	Australia	4000
5	Flinders Medical Centre	Adelaide	South Australia	Australia	5000
6	Royal Adelaide Hospital	Adelaide	South Australia	Australia	5000
7	The Alfred Hospital	Melbourne	Victoria	Australia	3004
8	Royal Perth Hospital	Perth	Western Australia	Australia	6000