Near Patient Microbial Testing in Cystic Fibrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-06-30

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.

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Detailed Description

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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?

Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cystic Fibrosis patients

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.

Group Type OTHER

home monitoring

Intervention Type OTHER

Record daily - peak flow measurements, pulse rate, oxygen saturation levels, weight,activity and daily sputum samples.

Interventions

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home monitoring

Record daily - peak flow measurements, pulse rate, oxygen saturation levels, weight,activity and daily sputum samples.

Intervention Type OTHER

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

Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No