Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000628640
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
12/10/2005
Date last updated
19/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acquisition and transmission of pulmonary Pseudomonas aeruginosa infection in patients with cystic fibrosis
Scientific title
Acquisition and transmission of pulmonary Pseudomonas aeruginosa infection in patients with cystic fibrosis
Secondary ID [1] 287943 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 756 0
Condition category
Condition code
Human Genetics and Inherited Disorders 832 832 0 0
Cystic fibrosis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 498 0
Early detection / Screening
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1068 0
To identify if aerosol contamination in the home environment provides the most likely source of P.aeruginosa for initial infection with P. aeruginosa
Timepoint [1] 1068 0
At time of testing
Primary outcome [2] 1069 0
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.
Timepoint [2] 1069 0
At time of testing
Secondary outcome [1] 1982 0
To provide practical solutions that will contain the risks of cross-infection and enable appropriate and optimal management of all patients with CF.
Timepoint [1] 1982 0
At time of analysis

Eligibility
Key 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.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Informed consent cannot be obtained.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/05/2005
Actual
6/10/2005
Date of last participant enrolment
Anticipated
31/12/2012
Actual
31/12/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 920 0
Charities/Societies/Foundations
Name [1] 920 0
RCH Foundation, Brisbane
Country [1] 920 0
Australia
Primary sponsor type
Individual
Name
A/Prof Claire Wainwright
Address
Herston Rd Herston
Country
Australia
Secondary sponsor category [1] 778 0
Individual
Name [1] 778 0
Dr Scott Bell
Address [1] 778 0
Rode Rd Chermside
Country [1] 778 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2208 0
Royal Children's Hospital
Ethics committee address [1] 2208 0
Ethics committee country [1] 2208 0
Australia
Date submitted for ethics approval [1] 2208 0
Approval date [1] 2208 0
01/12/2004
Ethics approval number [1] 2208 0
Ethics committee name [2] 2209 0
The Prince Charles Hospital
Ethics committee address [2] 2209 0
Ethics committee country [2] 2209 0
Australia
Date submitted for ethics approval [2] 2209 0
Approval date [2] 2209 0
Ethics approval number [2] 2209 0

Summary
Brief summary
This study has been designed to examine where first infections with Pseudomonas aeruginosa come from and also to examine the factors that may be important in how the organism might be passed from one person to another with CF.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35112 0
Prof Claire Wainwright
Address 35112 0
5a Respiratory & Sleep Medicine
Lady Cilento Children's Hospital
Brisbane
Country 35112 0
Australia
Phone 35112 0
+617 30681111
Fax 35112 0
Email 35112 0
[email protected]
Contact person for public queries
Name 9687 0
Ms Ms Joyce Cheney
Address 9687 0
5a Respiratory & Sleep Medicine
Lady Cilento Children's Hospital
Brisbane
Country 9687 0
Australia
Phone 9687 0
+617 30697195
Fax 9687 0
+617 30697159
Email 9687 0
[email protected]
Contact person for scientific queries
Name 615 0
Prof Claire Wainwright
Address 615 0
5a Respiratory & Sleep Medicine
Lady Cilento Children's Hospital
Brisbane
Country 615 0
Australia
Phone 615 0
+617 30681111
Fax 615 0
+617 30697159
Email 615 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.