Point of Care Testing Using FebriDx in Primary Care: a Mixed Methods Feasibility Study (PREFIX)

Point of Care Testing Using FebriDx to Improve Antibiotic Use for Respiratory Tract Infections in Primary Care: a Mixed Methods Feasibility Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lower Resp Tract Infection
• Intervention / Treatment: Diagnostic test: FebriDx

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

1. Explore whether FebriDx could reduce the use of antibiotics for chest infections in primary care.
2. 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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christopher Wilcox; Phone Number: 02380591759; Email: christopher.wilcox@soton.ac.uk
• Study Contact Backup: Name: Nick Francis; Email: nick.francis@soton.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Febridx; Undergo FebriDx testing	Diagnostic test: FebriDx; Testing of finger-prick blood sample using FebriDx

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	The proportion of patients recruited as compared to the number invited to participate	Six months
Antibiotic prescription rate at study visit	The proportion of patients prescribed antibiotics at the study visit	At study visit (baseline)
Antibiotic prescription rate over entire study period	The proportion of patients prescribed antibiotics within 30 days of recruitment	Within 30 days of recruitment
Test failure rate	The proportion of Febridx tests which fail to provide a valid result	After FebriDx use (baseline)
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)	Six months
Subsequent healthcare contacts	The proportion of patients undergoing subsequent healthcare contact	Within 30 days of recruitment
Subsequent serious complication rate	The proportion of patients undergoing significant complications (sepsis, ITU admission, or death)	Within 30 days of recruitment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Within one year

Collaborators and Investigators

• Sponsor: University of Southampton
• Investigators: Principal Investigator: Christopher Wilcox, University of Southampton

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2022
• Primary Completion (ANTICIPATED): October 1, 2023
• Study Completion (ANTICIPATED): October 1, 2024

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: September 7, 2022
• First Posted (ACTUAL): September 9, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 9, 2022
• Last Update Submitted That Met QC Criteria: September 7, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: 72411

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No