Lower Resp Tract InfectionPREFIXNCT05534555
Point of Care Testing Using FebriDx in Primary Care: a Mixed Methods Feasibility Study
A study testing FebriDx in people with Lower Resp Tract Infection, run by University of Southampton.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Lower Resp Tract Infection
- What is being tested?
- FebriDx
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who have taken antibiotics within the last 30 days
- Participant (or their parent/guardian) unable to provide informed consent
Trial locations and contacts
No sites are listed yet.
Nick Francis contact
About this study
Official title: 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.
Read the 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.
- Conditions
- Lower Resp Tract Infection
- Being tested
- FebriDx
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FebriDxDiagnostic test
Testing of finger-prick blood sample using FebriDx
| Study group | Role | What they receive |
|---|---|---|
| Febridx | Other | Undergo FebriDx testing Receives: Diagnostic Test: FebriDx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
The proportion of patients recruited as compared to the number invited to participate
Measured: Six months
Antibiotic prescription rate at study visit
The proportion of patients prescribed antibiotics at the study visit
Measured: At study visit (baseline)
Antibiotic prescription rate over entire study period
The proportion of patients prescribed antibiotics within 30 days of recruitment
Measured: Within 30 days of recruitment
Test failure rate
The proportion of Febridx tests which fail to provide a valid result
Measured: 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)
Measured: Six months
Subsequent healthcare contacts
The proportion of patients undergoing subsequent healthcare contact
Measured: Within 30 days of recruitment
Subsequent serious complication rate
The proportion of patients undergoing significant complications (sepsis, ITU admission, or death)
Measured: 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
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
Measured: Within one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study startOct 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Resp Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Wilcox, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534555
- Sponsor's protocol ID
- 72411
- Acronym
- PREFIX
- Status last verified
- Sep 2022
- First submitted
- 8 Jun 2022
- Last updated
- 9 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point of Care Testing Using FebriDx to Improve Antibiotic Use for Respiratory Tract Infections in Primary Care: a Mixed Methods Feasibility Study
- ClinicalTrials.gov ID
- NCT05534555
- Acronym / sponsor ID
- PREFIX / 72411
- Conditions
- Lower Resp Tract Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 9 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Febridx | Other | Diagnostic Test: FebriDxUndergo FebriDx testing |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who have taken antibiotics within the last 30 days
- Participant (or their parent/guardian) unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FebriDxTesting of finger-prick blood sample using FebriDx | Diagnostic test | Febridx |
Primary outcome
Recruitment rate
Time frame: Six months
The proportion of patients recruited as compared to the number invited to participate
Antibiotic prescription rate at study visit
Time frame: At study visit (baseline)
The proportion of patients prescribed antibiotics at the study visit
Antibiotic prescription rate over entire study period
Time frame: Within 30 days of recruitment
The proportion of patients prescribed antibiotics within 30 days of recruitment
Test failure rate
Time frame: After FebriDx use (baseline)
The proportion of Febridx tests which fail to provide a valid result
Ease-of-use scores
Time frame: 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
Time frame: Within 30 days of recruitment
The proportion of patients undergoing subsequent healthcare contact
Subsequent serious complication rate
Time frame: Within 30 days of recruitment
The proportion of patients undergoing significant complications (sepsis, ITU admission, or death)
1 secondary outcome
FebriDx sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for diagnosis of viral infection
Time frame: Within one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nick Francis contact
Christopher Wilcox principal investigator
University of Southampton
Questions about this trial
What is this clinical trial studying?
A study testing FebriDx in people with Lower Resp Tract Infection, run by University of Southampton.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christopher Wilcox (02380591759, christopher.wilcox@soton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Six months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2022.