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

NCT05534555 | Unknown

• 1 other identifier: 72411
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lower Resp Tract Infection

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• FebriDx sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for diagnosis of viral infection

  Within one year

Study Arms (1)

Febridx

OTHER

Undergo FebriDx testing

Diagnostic Test: FebriDx

Interventions

FebriDx DIAGNOSTIC_TEST

Testing of finger-prick blood sample using FebriDx

Febridx

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who have taken antibiotics within the last 30 days
• Participant (or their parent/guardian) unable to provide informed consent

Sponsors & Collaborators

• University of Southampton: lead

Study Officials

• Christopher Wilcox

  University of Southampton

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Wilcox

CONTACT

02380591759; christopher.wilcox@soton.ac.uk

Nick Francis

CONTACT

Nick.francis@soton.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: September 9, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2024
• Last Updated: September 9, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share