Point of Care Testing Using FebriDx in Primary Care: a Mixed Methods Feasibility Study (PREFIX)
Primary Purpose
Lower Resp Tract Infection
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FebriDx
Sponsored by
About this trial
This is an interventional diagnostic trial for Lower Resp Tract Infection
Eligibility Criteria
Inclusion Criteria:
- Lower respiratory tract infection (defined as in previous studies as an acute cough as the predominant symptom, judged by the GP to be infective in origin, lasting <21 days, and with other symptoms or signs localising to the lower respiratory tract (shortness of breath, sputum, chest pain). This is a definition which we have used in previous studies (22)
- The clinician has decided that they are likely to prescribe antibiotics in the absence of further diagnostic testing
- The patient is at the surgery or willing to attend the surgery for a face-to-face assessment
- The patient (or their parent or legal guardian) can follow the study procedures and is willing to provide informed consent
Exclusion Criteria:
- Patients who have taken antibiotics within the last 30 days
- Participant (or their parent/guardian) unable to provide informed consent
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Febridx
Arm Description
Undergo FebriDx testing
Outcomes
Primary Outcome Measures
Recruitment rate
The proportion of patients recruited as compared to the number invited to participate
Antibiotic prescription rate at study visit
The proportion of patients prescribed antibiotics at the study visit
Antibiotic prescription rate over entire study period
The proportion of patients prescribed antibiotics within 30 days of recruitment
Test failure rate
The proportion of Febridx tests which fail to provide a valid result
Ease-of-use scores
The average ease-of-use score for the device as determined by users.
Each user will be asked to grade the device according to a modified US Clinical Laboratory Improvement Amendments (CLIA) categorisation criteria
Within each of the 11 categories, a score of '1' indicates the lowest level of complexity, and the score of '3' indicates the highest level, to derive a measure of complexity (total score range 1 - 33)
Subsequent healthcare contacts
The proportion of patients undergoing subsequent healthcare contact
Subsequent serious complication rate
The proportion of patients undergoing significant complications (sepsis, ITU admission, or death)
Secondary Outcome Measures
FebriDx sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for diagnosis of viral infection
FebriDx sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for diagnosis of viral infection, as determined by comparison of FebriDx result with nasopharyngeal swab analysis by gold-standard viral PCR
Full Information
NCT ID
NCT05534555
First Posted
June 8, 2022
Last Updated
September 7, 2022
Sponsor
University of Southampton
1. Study Identification
Unique Protocol Identification Number
NCT05534555
Brief Title
Point of Care Testing Using FebriDx in Primary Care: a Mixed Methods Feasibility Study
Acronym
PREFIX
Official Title
Point of Care Testing Using FebriDx to Improve Antibiotic Use for Respiratory Tract Infections in Primary Care: a Mixed Methods Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southampton
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a mixed-methods, multi-centre feasibility study. Formal advice and peer-review with regards to study design was sought from the Southampton Research Design Service (RDS), the NIHR CRN Wessex, and patient contributors during the development of the grant application. We will recruit up to ten GP practices, each given 20-40 FebriDx tests (300 in total). Up to four clinicians per practice will be trained to use the test. A sequential explanatory approach to data collection will be taken (21), with quantitative data analysis in stage one, followed by qualitative interviews with the study's practice participants in stage two.
Detailed Description
It can be difficult to tell the difference between viral and bacterial infections. Many patients are therefore prescribed antibiotics unnecessarily. Overuse of antibiotics is leading to a crisis of 'antibiotic resistance', where antibiotics no longer work for some infections.
FebriDx ® is a new hand-held test that uses a 'finger-prick' of blood, and within 10 minutes, provides a result that can help clinicians decide whether an infection is likely to be caused by a virus or bacteria. This could help clinicians decide when antibiotics are needed, but the test has not been adequately tested in primary care.
We would like to do a future study to test whether FebriDx can safely reduce antibiotic prescriptions in primary care.
However, before we do this, we need to do a smaller 'feasibility' study to explore how easy to use the FebriDx test is and, what GPs and patients think of the test, and to help us design a larger future study.
Aims
Explore whether FebriDx could reduce the use of antibiotics for chest infections in primary care.
Explore how feasible it would be to do a large research study in the future using FebriDx
Methods
We will recruit up to ten GP practices, each given 20-40 FebriDx tests (300 total).
Stage one Patients with a chest infection will be invited to participate if their clinician has decided that they are likely to prescribe antibiotics. Following consent, the clinician will record some basic information about the patient, and the patient will undergo the FebriDx test. The clinician will then record whether or not they prescribed antibiotics and if they think the test had an effect on their decision. Patients will also undergo an optional nasopharyngeal swab.
Stage two Clinicians and patients will be interviewed on how useful they think FebriDx testing is, and how they think we should design a larger future study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Resp Tract Infection
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Febridx
Arm Type
Other
Arm Description
Undergo FebriDx testing
Intervention Type
Diagnostic Test
Intervention Name(s)
FebriDx
Intervention Description
Testing of finger-prick blood sample using FebriDx
Primary Outcome Measure Information:
Title
Recruitment rate
Description
The proportion of patients recruited as compared to the number invited to participate
Time Frame
Six months
Title
Antibiotic prescription rate at study visit
Description
The proportion of patients prescribed antibiotics at the study visit
Time Frame
At study visit (baseline)
Title
Antibiotic prescription rate over entire study period
Description
The proportion of patients prescribed antibiotics within 30 days of recruitment
Time Frame
Within 30 days of recruitment
Title
Test failure rate
Description
The proportion of Febridx tests which fail to provide a valid result
Time Frame
After FebriDx use (baseline)
Title
Ease-of-use scores
Description
The average ease-of-use score for the device as determined by users.
Each user will be asked to grade the device according to a modified US Clinical Laboratory Improvement Amendments (CLIA) categorisation criteria
Within each of the 11 categories, a score of '1' indicates the lowest level of complexity, and the score of '3' indicates the highest level, to derive a measure of complexity (total score range 1 - 33)
Time Frame
Six months
Title
Subsequent healthcare contacts
Description
The proportion of patients undergoing subsequent healthcare contact
Time Frame
Within 30 days of recruitment
Title
Subsequent serious complication rate
Description
The proportion of patients undergoing significant complications (sepsis, ITU admission, or death)
Time Frame
Within 30 days of recruitment
Secondary Outcome Measure Information:
Title
FebriDx sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for diagnosis of viral infection
Description
FebriDx sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for diagnosis of viral infection, as determined by comparison of FebriDx result with nasopharyngeal swab analysis by gold-standard viral PCR
Time Frame
Within one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Lower respiratory tract infection (defined as in previous studies as an acute cough as the predominant symptom, judged by the GP to be infective in origin, lasting <21 days, and with other symptoms or signs localising to the lower respiratory tract (shortness of breath, sputum, chest pain). This is a definition which we have used in previous studies (22)
The clinician has decided that they are likely to prescribe antibiotics in the absence of further diagnostic testing
The patient is at the surgery or willing to attend the surgery for a face-to-face assessment
The patient (or their parent or legal guardian) can follow the study procedures and is willing to provide informed consent
Exclusion Criteria:
Patients who have taken antibiotics within the last 30 days
Participant (or their parent/guardian) unable to provide informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Wilcox
Phone
02380591759
Email
christopher.wilcox@soton.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Nick Francis
Email
Nick.francis@soton.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Wilcox
Organizational Affiliation
University of Southampton
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Point of Care Testing Using FebriDx in Primary Care: a Mixed Methods Feasibility Study
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