Near Patient Microbial Testing in Cystic Fibrosis

February 16, 2016 updated by: Judy Ryan, Papworth Hospital NHS Foundation Trust

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Cambridge, United Kingdom, CB23 3RE
        • Papworth Hospital NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Other: home monitoring
Record daily - peak flow measurements, pulse rate, oxygen saturation levels, weight,activity and daily sputum samples.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Advance warning of an infective exacerbation
Time Frame: 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.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
home monitoring of multiple physiological parameters
Time Frame: 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.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Papworth Hospital NHS Foundation Trust

Investigators

  • Principal Investigator: Andres Floto, MA, MRCP, Papworth Hospital NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

June 7, 2013

First Submitted That Met QC Criteria

June 11, 2013

First Posted (Estimate)

June 14, 2013

Study Record Updates

Last Update Posted (Estimate)

February 17, 2016

Last Update Submitted That Met QC Criteria

February 16, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12/EE/0462

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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