Near Patient Microbial Testing in Cystic Fibrosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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%? 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? 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? 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?

Official Title
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A Home-based, Rapid and Quantitative Test for Bacterial Respiratory Infections in Patients With Cystic Fibrosis, to Reduce Admissions and Hospital Stay Length and to Improve Healthcare Outcomes.

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Other: home monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cystic Fibrosis patients<br>Patients with a diagnosis of cystic fibrosis, who are able to produce daily sputum samples. With a history of at least two pulmonary infective exacerbations within the past 12 months. | Other: home monitoring<br>* Record daily - peak flow measurements, pulse rate, oxygen saturation levels, weight,activity and daily sputum samples.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Advance warning of an infective exacerbation | 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. Participants will collect daily sputum samples which will be profiled for psuedomonas aeruginosa. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| home monitoring of multiple physiological parameters | Daily peak flow measurements will be obtained for FEV1 and PEF Daily pulse rate and oxygen saturations levels Participants will weigh themselves daily on study specfic scales Participants will wear a step counter during waking hours to measure their activity levels. | one year |