A Prospective Study to Examine the Effectiveness and Safety of Neuraminidase Inhibitors in Index Cases With Presumed Pandemic Influenza
- Conditions
- Pandemic Influenza
- Registration Number
- NCT00640302
- Lead Sponsor
- Kirby Institute
- 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.
- 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).
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- none
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mortality One month
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Flinders Medical Centre
🇦🇺Adelaide, South Australia, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Royal Brisbane Hospital
🇦🇺Brisbane, Queensland, Australia
Westmead Hospital
🇦🇺Sydney, New South Wales, Australia
St Vincent's Hospital
🇦🇺Sydney, New South Wales, Australia
Prince of Wales Hospital
🇦🇺Sydney, New South Wales, Australia
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia