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

Not Applicable

Not yet recruiting

• Conditions: Lower Resp Tract Infection
• Interventions: Diagnostic Test: FebriDx

• Registration Number: NCT05534555
• Lead Sponsor: University of Southampton

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

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 Timeline

• Study First Submitted: 2022-06-08
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-07
• Last Update Submitted: 2022-09-07
• Study First Posted: 2022-09-09
• Last Update Posted: 2022-09-09
• Study Start: 2022-10
• Primary Completion: 2023-10
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Febridx	FebriDx	Undergo FebriDx testing

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
FebriDx sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for diagnosis of viral infection	Within one year	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