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A Prospective Study to Examine the Effectiveness and Safety of Antivirals in Volunteers Who Receive Short-Term Prophylaxis Against Pandemic Influenza (PIPET C)

This study is not yet open for participant recruitment.
Verified by The National Centre in HIV Epidemiology and Clinical Research, March 2008

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: NCT00640874
  Purpose

This aim of this project is to evaluate the efficacy of neuraminidase inhibitors as short-term prophylaxis against pandemic influenza infection in people who have close familial contact with the disease. The study is observational only. The primary measure used in this study will be the incidence of symptomatic pandemic influenza in patients receiving prophylaxis. Seroconversion to pandemic influenza, the incidence of adverse events and the relative effectiveness of oseltamivir and zanamivir prophylaxis 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

MedlinePlus related topics:   Flu   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective
Official Title:   A Prospective Study to Examine the Effectiveness and Safety of Antivirals in Volunteers Who Receive Short-Term Prophylaxis Against Pandemic Influenza.

Further study details as provided by The National Centre in HIV Epidemiology and Clinical Research:

Primary Outcome Measures:
  • The primary measure used in this study will be the incidence of symptomatic pandemic influenza in patients receiving prophylaxis. [ Time Frame: One month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Seroconversion to pandemic influenza, the incidence of adverse events and the relative effectiveness of oseltamivir and zanamivir prophylaxis will also be examined. [ Time Frame: One month ] [ Designated as safety issue: No ]

Estimated Enrollment:   500

Groups/Cohorts
PIPET C
Contact group members of people with diagnosed influenza who are recommended to receive NA inhibitor prophylaxis for short periods of time will be enrolled following provision of informed consent.

Detailed Description:

The aim of this study is to

  1. Describe the effectiveness of short-term prophylaxis against symptomatic pandemic influenza infection
  2. Describe the safety of short-term prophylaxis
  3. Describe the seroconversion rate against pandemic influenza among recipients of short-term prophylaxis

The study is an open label prospective cohort study. Contact group members of people with diagnosed influenza who are recommended to receive NA inhibitor prophylaxis for short periods of time will be enrolled following provision of informed consent. Each episode of short-term prophylaxis will be recorded separately.

By design it is hoped that volunteers in this study who develop symptoms and signs of pandemic influenza infection will be enrolled in the Index Case (PIPET A) protocol with follow-up as required.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample

Study Population

Contact group members of people with diagnosed influenza who are recommended to receive NA inhibitor prophylaxis for short periods of time will be enrolled following provision of informed consent. Each episode of short-term prophylaxis will be recorded separately.


Criteria

Inclusion Criteria:

  • Provision of written informed consent
  • Intention to commence or have commenced short-term prophylaxis with a neuraminidase inhibitor in individuals who have been exposed to the pandemic virus

Exclusion Criteria:

  • none
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640874

Locations
Australia, New South Wales
Prince of Wales Hospital    
      Sydney, New South Wales, Australia, 2031
      Contact: Suzanne Ryan     61 2 9382 3408     Suzanne.Ryan@SESIAHS.HEALTH.NSW.GOV.AU    
      Principal Investigator: Kathleen Clezy            
St Vincent's Hospital    
      Sydney, New South Wales, Australia, 2010
      Contact: Richard Norris     61 2 8382 2435     rnorris@stvincents.com.au    
      Principal Investigator: David A Cooper            
Westmead Hospital    
      Sydney, New South Wales, Australia, 2145
      Contact: Margaret Piper     +61 2 9845 6251     margaret_piper@wmi.usyd.edu.au    
      Principal Investigator: Dominic Dwyer            
Australia, Queensland
Royal Brisbane Hospital    
      Brisbane, Queensland, Australia, 4000
      Contact: Janelle Zillman     +61 7 3636 7324     Janelle_Zillmann@health.qld.gov.au    
      Principal Investigator: Anthony Allworth            
Australia, South Australia
Flinders Medical Centre    
      Adelaide, South Australia, Australia, 5042
      Contact: Michelle Wall     61 8 8204 4292     Michelle.Wall@fmc.sa.gov.au    
      Principal Investigator: David Gordon            
Royal Adelaide Hospital    
      Adelaide, South Australia, Australia, 5000
      Contact: Lyndal Daly     61 8 8222 5635     ldaly@mail.rah.sa.gov.au    
      Principal Investigator: David Shaw            
Australia, Victoria
The Alfred Hospital    
      Melbourne, Victoria, Australia, 3004
      Contact: Janine Roney     61 3 9076 6908     clinresearch@alfred.org.au    
      Principal Investigator: Jennifer Hoy            
Australia, Western Australia
Royal Perth Hospital    
      Perth, Western Australia, Australia, 6000
      Contact: Claire Forsdyke     61 8 9224 3427     claire.forsdyke@health.wa.gov.au    
      Principal Investigator: James Flexman            

Sponsors and Collaborators
The National Centre in HIV Epidemiology and Clinical Research
National Health and Medical Research Council, Australia

Investigators
Principal Investigator:     Dominic Dwyer     Westmead Hospital    
  More Information


Responsible Party:   Therapeutic and Vaccine Research Program, National Centre in HIV Epidemiology and Clinical Research, University of New South Wales ( Sean Emery )
Study ID Numbers:   PIPET C
First Received:   March 17, 2008
Last Updated:   March 17, 2008
ClinicalTrials.gov Identifier:   NCT00640874
Health Authority:   Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by The National Centre in HIV Epidemiology and Clinical Research:
Prophylaxis  
pandemic influenza  
influenza A  
H5N1 virus  

Study placed in the following topic categories:
Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:
RNA Virus Infections

ClinicalTrials.gov processed this record on October 17, 2008




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