None listed
Conditions
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.
Interventions
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.
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.
Sponsors
A/Prof Scott Bell (Principle Investigator)
Eligibility
Sex/Gender
All
Age
2 Years to 75 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed