Near Patient Microbial Testing in Cystic Fibrosis
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.
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 7, 2013
CompletedFirst Posted
Study publicly available on registry
June 14, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedFebruary 17, 2016
February 1, 2016
4 months
June 7, 2013
February 16, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
home monitoring of multiple physiological parameters
one year
Study Arms (1)
Cystic Fibrosis patients
OTHERPatients 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.
Interventions
Record daily - peak flow measurements, pulse rate, oxygen saturation levels, weight,activity and daily sputum samples.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Unable to provide written informed consent
- Patients unable to produce daily sputum samples
- Fewer than two infective pulmonary exacerbations in 12 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Papworth Hospital NHS Trust
Cambridge, CB23 3RE, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andres Floto, MA, MRCP
Papworth Hospital NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research & Database Manager
Study Record Dates
First Submitted
June 7, 2013
First Posted
June 14, 2013
Study Start
January 1, 2013
Primary Completion
May 1, 2013
Study Completion
June 1, 2014
Last Updated
February 17, 2016
Record last verified: 2016-02