|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
The National Centre in HIV Epidemiology and Clinical Research National Health and Medical Research Council, Australia |
|---|---|
| Information provided by: | The National Centre in HIV Epidemiology and Clinical Research |
| ClinicalTrials.gov Identifier: | NCT00640302 |
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: | Cohort, Prospective |
| Official Title: | A Prospective Study to Examine the Effectiveness and Safety of Neuraminidase Inhibitors in Index Cases With Presumed Pandemic Influenza Infection |
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.
| Estimated Enrollment: | 1000 |
| 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).
|
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 |
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).
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Allison Humphries, BSc, MSc, Grad Dip Pub Hlth | +61 2 9385 0900 | ahumphries@nchecr.unsw.edu.au |
| Contact: Sean Emery, BSc (Hons) PhD | +61 2 9385 0900 | semery@nchecr.unsw.edu.au |
| 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 | |
| Principal Investigator: | Dominic Dwyer, FRACP, FRCPA, MD | Sydney West Area Health Service |
More Information
| Responsible Party: | The National Centre in HIV Epidemiology and Clinical Research ( Associate Professor Sean Emery ) |
| Study ID Numbers: | PIPET A |
| Study First Received: | March 16, 2008 |
| Last Updated: | March 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00640302 History of Changes |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
|
Index cases pandemic influenza influenza A H5N1 virus |
|
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Influenza, Human Influenza in Birds Orthomyxoviridae Infections |
|
Virus Diseases RNA Virus Infections Respiratory Tract Diseases |
Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |
