Near Patient Microbial Testing in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01877707
• Other study ID #: 12/EE/0462
• Status: Completed
• Phase: N/A
• First received: June 7, 2013
• Last updated: February 16, 2016
• Start date: January 2013
• Est. completion date: June 2014

Study information

• Verified date: February 2016
• Source: Papworth Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Other:
• home monitoring
Record daily - peak flow measurements, pulse rate, oxygen saturation levels, weight,activity and daily sputum samples.

Locations

Country	Name	City	State
United Kingdom	Papworth Hospital NHS Trust	Cambridge

Sponsors (1)

Lead Sponsor	Collaborator
Papworth Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No