An interventional study of FebriDx in Lower Resp Tract Infection, sponsored by University of Southampton. Status unknown. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2022-09-09.
Sponsored by University of Southampton · Not applicable, Interventional, and Diagnostic
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.
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
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 300 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →University of Southampton is the lead sponsor of 121 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Undergo FebriDx testing
Diagnostic Test: FebriDx
Testing of finger-prick blood sample using FebriDx
Recruitment rate
The proportion of patients recruited as compared to the number invited to participate
Time frame: Six months
Antibiotic prescription rate at study visit
The proportion of patients prescribed antibiotics at the study visit
Time frame: At study visit (baseline)
Antibiotic prescription rate over entire study period
The proportion of patients prescribed antibiotics within 30 days of recruitment
Time frame: Within 30 days of recruitment
Test failure rate
The proportion of Febridx tests which fail to provide a valid result
Time frame: 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)
Time frame: Six months
Subsequent healthcare contacts
The proportion of patients undergoing subsequent healthcare contact
Time frame: Within 30 days of recruitment
Subsequent serious complication rate
The proportion of patients undergoing significant complications (sepsis, ITU admission, or death)
Time frame: Within 30 days of recruitment
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
Time frame: Within one year
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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University of Southampton