Near Patient Microbial Testing in Cystic Fibrosis

NHS Foundation Trust

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Other: home monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT01877707

12/EE/0462

Details and patient eligibility

About

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.

Full description

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?

Enrollment: 16 patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Cystic Fibrosis patients

Other group

Description:

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.

Treatment:

Other: home monitoring