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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12605000628640 |
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Date of registration:
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12/10/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Acquisition and transmission of pulmonary Pseudomonas aeruginosa infection in patients with cystic fibrosis
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Scientific title:
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Acquisition and transmission of pulmonary Pseudomonas aeruginosa infection in patients with cystic fibrosis |
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Date of first enrolment:
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06/10/2005 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://anzctr.org.au/ACTRN12605000628640.aspx |
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Study type:
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Observational |
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Study design:
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Purpose: Natural history;Duration: Longitudinal;Selection: Defined population;Timing: Prospective;
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Phase:
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Not Applicable
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Countries of recruitment
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Australia
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Contacts
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Name:
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Prof Claire Wainwright
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Address:
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5a Respiratory & Sleep Medicine
Lady Cilento Children's Hospital
Brisbane
Australia |
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Telephone:
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+617 30681111 |
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Email:
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Claire.Wainwright@health.qld.gov.au |
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Affiliation:
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Name:
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Ms Ms Joyce Cheney
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Address:
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5a Respiratory & Sleep Medicine
Lady Cilento Children's Hospital
Brisbane
Australia |
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Telephone:
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+617 30697195 |
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Email:
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Joyce.Cheney@health.qld.gov.au |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Children and adults diagnosed with cystic fibrosis at Royal Children's Hospital, Brisbane and The Prince Charles Hospital, Brisbane Informed consent from patients or parents/guardians.
Exclusion criteria: Informed consent cannot be obtained.
Age minimum:
Not stated
Age maximum:
Not stated
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Human Genetics and Inherited Disorders - Cystic fibrosis
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Cystic Fibrosis;
Cystic Fibrosis
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Intervention(s)
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This project is divided into four parts. Part one is designed to examine whether early acquisition of P.aeruginosa in young children with CF is associated with environmental sources of P.aeruginosa in the home. Part two is a methodology study designed to screen large numbers of microbiological samples for the predominant Brisbane clonal strain of P.aeruginosa. Part three allows an opportunity to explore the possible relationship between molecular factors that may be involved in acquisition and transmission of clonal strains of P.aeruginosa. Part four examines culturable cough generated aerosols in patients with CF and an examination of clinical factors that may be involved in aerosol transmission of P.aeruginosa. It is anticipated that environmental sampling may take up to 2 years to complete and that clinical air sampling will take up to 12 months to complete.
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Primary Outcome(s)
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To identify if aerosol contamination in the home environment provides the most likely source of P.aeruginosa for initial infection with P. aeruginosa[At time of testing]
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To determine if transmission of P. aeruginosa is related to exposure time and infective load of aerosolised P. aeruginosa and specific virulence factors associated with the organism.[At time of testing]
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Secondary Outcome(s)
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To provide practical solutions that will contain the risks of cross-infection and enable appropriate and optimal management of all patients with CF.[At time of analysis]
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Secondary ID(s)
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Nil known
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Source(s) of Monetary Support
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RCH Foundation, Brisbane
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Ethics review
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Status: Approved
Approval date:
Contact:
Royal Children's Hospital
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Status: Not approved
Approval date:
Contact:
The Prince Charles Hospital
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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