ANZCTR - Registration

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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.

Condition category

Condition code

Infection

Studies of infection and infectious agents

Human Genetics and Inherited Disorders

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]

None

Comparator / control treatment

Presence (comparator) or absence (control) of a clonal P.aeruginosa strain.

Control group

Historical

Outcomes

Primary outcome [1]

Adverse change in the clinical status of the participants that have a clonal P.aeruginosa strain.

Timepoint [1]

At the completion of the Observational Study (i.e. after 5 years).

Secondary outcome [1]

Incidence of infection and risk factors for acquistion of clonal strains

Timepoint [1]

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?

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]

Government body

Name [1]

National Health and Medical Research Council (NHMRC) Project Grant

Address [1]

GPO Box 1421
Canberra ACT 2601

Country [1]

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]

Individual

Name [1]

Mr Timothy Kidd (Study Coordinator)

Address [1]

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]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Prince Charles Hospital

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

EC00168

Ethics committee name [2]

Royal Children's Hospital

Ethics committee address [2]

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

Ethics approval number [2]

EC00175

Ethics committee name [3]

Royal Adelaide Hospital

Ethics committee address [3]

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

Approval date [3]

Ethics approval number [3]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Mr Timothy Kidd (Study Coordinator)

Address

Queensland Paediatric Infectious Dieases
Laboratory
Sir Albert Sakzewski Virus Research Centre (SASVRC)
Level 7
Royal Children's Hospital
Herston Rd
Herston QLD 4029

Country

Australia

Phone

+61 7 36361618

Fax

+61 7 36361401

Tim_Kidd@health.qld.gov.au

Contact person for scientific queries

Name

Associate Professor Scott Bell (Principle Investigator)

Address

Adult Cystic Fibrosis Centre
The Prince Charles Hospital
Rode Rd
Chermside QLD 4032

Country

Australia

Phone

+61 7 31394406

Fax

+61 7 31395630

Scott_Bell@health.qld.gov.au

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.

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