Near Patient Microbial Testing in Cystic Fibrosis
Near Patient Microbial Testing in Cystic Fibrosis
To identify whether home monitoring of multiple physiological parameters and biomarkers in
 sputum could provide advanced warning of an infective exacerbation or treatment failure
 before changes in patient-reported symptoms.
1. To determine if longitudinal profiling of sputum from Cystic Fibrosis patients allow
 accurate prediction of exacerbations in a study of a larger group and can we confirm the
 7+ day early warning system works in this larger group.

 2. Is one biomarker sufficient to predict exacerbations - what is the accuracy? Are two or
 more biomarkers required to achieve an accuracy of greater than 95%?

 3. Can we now accurately determine how many hospital bed days a home testing/wellness
 monitoring device would save? What is the business case for healthcare providers to
 adopt our future test for home use? We estimate a 50% saving. Can this be confirmed?

 4. When used in the clinic, how many hospital days would our test save through faster
 determination of treatment efficacy? What is the business case for adopting our future
 test as a point of care test on the ward in Cystic Fibrosis centres? Could this be the
 new revolutionary tool that we anticipate?

 5. We forecast a 50% reduction in costs to treat Cystic Fibrosis patients in disease
 severity bands 2-A to 5. Can we provide evidence for this to support further investment?
Inclusion Criteria:

 -  Diagnosis of Cystic Fibrosis based on genetic testing and/or sweat chloride levels.

 -  Chronic infection with Pseudomonas aeruginosa.

 -  Patients able to produce daily sputum samples.

 -  Current history of at least two pulmonary infective exacerbations in the past 12
 months.

 -  Able to give written informed consent

 Exclusion Criteria:

 -  Unable to provide written informed consent

 -  Patients unable to produce daily sputum samples

 -  Fewer than two infective pulmonary exacerbations in 12 months