Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000349448
Ethics application status
Approved
Date submitted
27/06/2007
Date registered
28/06/2007
Date last updated
3/09/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of the clinical impact of related (clonal) Pseudomonas aeruginosa strains in people with cystic fibrosis (CF).
Scientific title
A comparative assessment of the clinical impact of clonal Pseudomonas aeruginosa strains in people with cystic fibrosis (CF).
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clonal P. aeruginosa infection in patients with cystic fibrosis. 1906 0
Condition category
Condition code
Infection 1996 1996 0 0
Studies of infection and infectious agents
Human Genetics and Inherited Disorders 1997 1997 0 0
Cystic fibrosis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A cross sectional study will be initially conducted among patients who attend 19 CF centres in Australia. These patients will be able to spontaneously produce sputum and are chronically infected with P. aeruginosa. (approximately 1500 patients). Sputum samples will be screened for the presence of related (clonal) P. aeruginosa strains over a period of six months. This will establish the prevalence and extent of current spread of these strains amongst adult and paediatric CF centres in Australia.

Following the cross sectional study, a longitudinal (observational) study (duration = 4 years) will be performed on any patients who are identified as free of infection from clonal strains. Each participant will be screened annually for the acquisition of any clonal strains. This study will determine the incidence of infection with clonal strains and any associated epidemiological risk factors for their acquisition. In addition, each patient’s clinical course will be monitored to determine if infection with a clonal strain is associated with an adverse clinical course and whether clinical or microbiological features predispose to or potentiate this effect.
Intervention code [1] 1857 0
None
Comparator / control treatment
Presence (comparator) or absence (control) of a clonal P.aeruginosa strain.
Control group
Historical

Outcomes
Primary outcome [1] 2819 0
Adverse change in the clinical status of the participants that have a clonal P.aeruginosa strain.
Timepoint [1] 2819 0
At the completion of the Observational Study (i.e. after 5 years).
Secondary outcome [1] 4752 0
Incidence of infection and risk factors for acquistion of clonal strains
Timepoint [1] 4752 0
At 2, 3, 4 & 5 years; Risk factors - at the completion of the Observational Study (i.e. after 5 years).

Eligibility
Key inclusion criteria
Children, adolescents and adults (both males and females) with CF who can produce a spontaneously expectorated sputum sample with evidence of P. aeruginosa (this will apply to both the Prevalence and Observational Studies). 2) Following the Cross sectional Study, only those patients without evidence of clonal strains will continue to have samples and clinical data collected for the Observational Study.
Minimum age
2 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Patient's that are unable to produce a spontaneously expectorated sputum sample or those who have no evidence of P. aeruginosa. 2) Patient's with evidence of a clonal strain at the completion of the Prevalence Study, will not be included in the Observational Study. 3) Any patient that is unable or unwilling to provide written informed consent.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2138 0
Government body
Name [1] 2138 0
National Health and Medical Research Council (NHMRC) Project Grant
Country [1] 2138 0
Australia
Primary sponsor type
Individual
Name
A/Prof Scott Bell (Principle Investigator)
Address
Adult Cystic Fibrosis Centre The Prince Charles Hospital Rode Rd Chermside QLD 4032
Country
Australia
Secondary sponsor category [1] 1942 0
Individual
Name [1] 1942 0
Mr Timothy Kidd (Study Coordinator)
Address [1] 1942 0
Queensland Paediatric Infectious Dieases Laboratory Sir Albert Sakzewski Virus Research Centre (SASVRC) Level 7 Royal Children's Hospital Herston Rd Herston QLD 4029
Country [1] 1942 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3932 0
The Prince Charles Hospital
Ethics committee address [1] 3932 0
Ethics committee country [1] 3932 0
Australia
Date submitted for ethics approval [1] 3932 0
Approval date [1] 3932 0
Ethics approval number [1] 3932 0
EC00168
Ethics committee name [2] 3933 0
Royal Children's Hospital
Ethics committee address [2] 3933 0
Ethics committee country [2] 3933 0
Australia
Date submitted for ethics approval [2] 3933 0
Approval date [2] 3933 0
Ethics approval number [2] 3933 0
EC00175
Ethics committee name [3] 3934 0
Royal Adelaide Hospital
Ethics committee address [3] 3934 0
Ethics committee country [3] 3934 0
Australia
Date submitted for ethics approval [3] 3934 0
Approval date [3] 3934 0
Ethics approval number [3] 3934 0
EC00192

Summary
Brief summary
In patients with cystic fibrosis (CF), recurring infection causes inflammation and airway damage. This study focuses on the major bacterial problem, Pseudomonas aeruginosa. Several studies from Australia and the UK including our own have shown that about 30-45% of patients share the same strain of P. aeruginosa within a Centre. We know that two dominant strains of P. aeruginosa are found in CF Centres on the eastern board of Australia. The emergence of these clonal strains is causing increasing anxiety in the CF community.

A cross sectional study will be initially conducted among patients who attend 19 CF centres in Australia. These patients will be able to spontaneously produce sputum and are chronically infected with P. aeruginosa (approximately 1500 patients). Sputum samples will be screened for the presence of related (clonal) P. aeruginosa strains. The aim of this cross sectional study is to establish the prevalence and extent of current spread of these strains amongst adult and paediatric CF centres in Australia.

Following the prevalence study, a second longitudinal (observational) study will be performed on any patients who are identified as free of infection from clonal strains. In this study each patient’s clinical course and clonal P.aeruginosa status will be monitored over a period of 4 years. The aims of this study are: i) to determine the incidence of infection with clonal strains and any associated epidemiological risk factors for their acquisition; and ii) to determine if infection with a clonal strain is associated with an adverse clinical course and whether clinical or microbiological features predispose to or potentiate this effect.

This study is designed to provide vitally needed information on the clinical implications of being infected by a clonal strain of P. aeruginosa and the risk factors for the acquisition of a clonal strain. This new information will provide a rational basis for the need for changes to infection control policies and better outcome predictors for patients infected with clonal strains of P. aeruginosa.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27671 0
Address 27671 0
Country 27671 0
Phone 27671 0
Fax 27671 0
Email 27671 0
Contact person for public queries
Name 11046 0
Mr Timothy Kidd (Study Coordinator)
Address 11046 0
Queensland Paediatric Infectious Dieases
Laboratory
Sir Albert Sakzewski Virus Research Centre (SASVRC)
Level 7
Royal Children's Hospital
Herston Rd
Herston QLD 4029
Country 11046 0
Australia
Phone 11046 0
+61 7 36361618
Fax 11046 0
+61 7 36361401
Email 11046 0
[email protected]
Contact person for scientific queries
Name 1974 0
Associate Professor Scott Bell (Principle Investigator)
Address 1974 0
Adult Cystic Fibrosis Centre
The Prince Charles Hospital
Rode Rd
Chermside QLD 4032
Country 1974 0
Australia
Phone 1974 0
+61 7 31394406
Fax 1974 0
+61 7 31395630
Email 1974 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.

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