Near Patient Microbial Testing in Cystic Fibrosis

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Other: home monitoring

• Registration Number: NCT01877707
• Lead Sponsor: Papworth Hospital NHS Foundation Trust

Brief Summary

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

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?

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-05
• Study First Submitted: 2013-06-07
• Study First Submitted QC: 2013-06-11
• Study First Posted: 2013-06-14
• Study Completion: 2014-06
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-16
• Last Update Posted: 2016-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cystic Fibrosis patients	home monitoring	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.

Primary Outcome Measures

Name	Time	Method
Advance warning of an infective exacerbation	one year	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.

Secondary Outcome Measures

Name	Time	Method
home monitoring of multiple physiological parameters	one year	1. Daily peak flow measurements will be obtained for FEV1 and PEF; 2. Daily pulse rate and oxygen saturations levels; 3. Participants will weigh themselves daily on study specfic scales; 4. Participants will wear a step counter during waking hours to measure their activity levels.

Trial Locations

Locations (1)

Papworth Hospital NHS Trust; 🇬🇧 Cambridge, United Kingdom