Pandemic InfluenzaPIPET ANCT00640302
A Prospective Study to Examine the Effectiveness and Safety of Neuraminidase Inhibitors in Index Cases With Presumed Pandemic Influenza
An observational study of Pandemic Influenza, run by Kirby Institute at 8 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pandemic Influenza
- How many people
- 0 participants
- Where
- 8 sitesAustralia
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Australia8 sites
Flinders Medical Centre
Adelaide, South Australia, 5000
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Royal Brisbane Hospital
Brisbane, Queensland, 4000
The Alfred Hospital
Melbourne, Victoria, 3004
Royal Perth Hospital
Perth, Western Australia, 6000
St Vincent's Hospital
Sydney, New South Wales, 2010
Prince of Wales Hospital
Sydney, New South Wales, 2031
Westmead Hospital
Sydney, New South Wales, 2145
About this study
Official title: A Prospective Study to Examine the Effectiveness and Safety of Neuraminidase Inhibitors in Index Cases With Presumed Pandemic Influenza Infection
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.
Read the 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).
- Conditions
- Pandemic Influenza
- Keywords
- Index cases, pandemic influenza, influenza A, H5N1 virus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pandemic InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Collaborators
- National Health and Medical Research Council, Australia
- Investigators
- Dominic Dwyer, FRACP, FRCPA, MD, Principal investigator, Westmead Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00640302
- Sponsor's protocol ID
- PIPET A
- Acronym
- PIPET A
- Status last verified
- Apr 2012
- First submitted
- 16 Mar 2008
- Last updated
- 24 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Examine the Effectiveness and Safety of Neuraminidase Inhibitors in Index Cases With Presumed Pandemic Influenza Infection
- ClinicalTrials.gov ID
- NCT00640302
- Acronym / sponsor ID
- PIPET A / PIPET A
- Conditions
- Pandemic Influenza
- Keywords
- Index cases, pandemic influenza, influenza A, H5N1 virus
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Collaborators
- National Health and Medical Research Council, Australia
- First posted
- 21 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: One month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominic Dwyer, FRACP, FRCPA, MD principal investigator
Westmead Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pandemic Influenza, run by Kirby Institute at 8 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2012.