Acute Respiratory InfectionASPIRE INCT06912022
ASPIRE I: Supporting Antibiotic Stewardship in Primary Care Via POCT
An observational study of Acute Respiratory Infection, run by University of South Wales at 2 sites in United Kingdom.
Trial summary
The ASPIRE study is an uncontrolled observational feasibility study, and a collaboration between the University of South Wales and Cwm Taf Morgannwg University Health Board (CTMUHB). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Respiratory Infection
- What is being tested?
- FebriDx Device
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 12 Sep 2022to 1 Jan 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be recruited from self-referred patients attending YCR and KHPC centres with a self-suspected acute respiratory infection (ARI). The study aims to collect a minimum of 140 participants using a pragmatic sampling regime. The feasibility study will provide the data required to design and conduct a more detailed and statistically powered trial.
Who may be able to join
- Subject >18 years of age.
- Having new onset symptoms suggestive of acute respiratory infection (ARI within 7 days of seeking care: runny nose, nasal congestion, sore throat, cough, hoarse voice, softness of breath) with or without fever.
Who cannot join
- Unable to provide informed consent.
- Undergoing end of life care.
- Immunocompromised or taking chemotherapy, oral steroids, or interferon.
- Receiving a live vaccine in the last 14 days.
- Taking antibiotics or antivirals in the last 14 days.
- Patients that are systematically unwell or having symptoms that lasted more than 7 days*.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Keir Hardie Practice 3
Cardiff
Ysbyty Cwm Rhondda
Cardiff
About this study
Official title: Supporting Antibiotic Stewardship in Primary Care Via Point-of-care Testing (POCT) for Acute Respiratory Tract Infections
The ASPIRE study is an uncontrolled observational feasibility study, and a collaboration between the University of South Wales and Cwm Taf Morgannwg University Health Board (CTMUHB). The study is based at Ysbyty Cwm Rhondda (YCR) and Keir Hardy Primary Care (KHPC) centres, where participant recruitment will take place. Study participants will be invited to provide capillary blood samples (via finger prick sampling) for testing. The principal investigators are Dr Aled Davies at YCR and Dr Shyama Velupillai at KHPC. Upon clinical assessment, and after provision of consent, participants will undergo an ARI (acute respiratory infection) POC assay. This is a dual marker immunoassay designed to detect raised levels of C-reactive protein and MxA in capillary blood. The assay uses the sensitivity of CRP and specify of MxA to aid in the differentiation of ARI's in Primary Care.
The POC assay results will be compared to the participants clinical outcomes and the physician directed treatment pathway via reviewing medical records and by contacting the patient from 14 days after their visit.
Read the detailed description
Antibiotic stewardship is fast becoming an essential measure to improve antibiotic prescribing by clinicians. Antibiotic stewardship not only presents a cost-effective strategy for the NHS but addressed the issue of antimicrobial resistance (AMR) and protects patients from harm caused by unnecessary antibiotic use.
The economic costs of antibiotic resistance are largely unknown, but it is anticipated that with an increased number of cases, effects to the economy could be severe. Infections and infectious diseases cost England \& Wales an estimated £30 billion a year, with many cases of acute respiratory infections (Chaplin, 2017). POC diagnostic tests in a clinical setting could give clinicians the ability to distinguish between microbial and viral infections, providing a more informed decision to antibiotic prescribing.
The purpose of this study is to safely distinguish between bacterial or viral respiratory infections in a primary care setting using "point of care" (POC) testing to provide a retrospective insight as to whether clinical assessment of an acute respiratory infection (ARI) is justified. Upon clinical assessment, the current clinical practice prescribes antibiotics based on symptoms reported by the patient and a subjective review by the GP. This results in antibiotics being prescribed from an informed decision made by the clinician, based only from patient symptoms. The use of a dual marker immunoassay could guide informed decisions based on qualitative data and degree of infection using POC testing in Primary Care.
The POC assay uses a dual marker immunoassay to differentiate between a viral and bacterial infection. C-reactive protein (CRP) is raised in the blood stream in response to inflammation. CRP can be elevated in viral infections, but generally the rise is to higher levels in bacterial infections, especially severe bacterial infections. Another blood protein, the MxA protein, is selectively increased in people with viral infections and therefore has the potential to greatly enhance the rapid distinction between viral and bacterial respiratory infections.
NICE guidance from 2014 recommends the use of CRP POC test in the diagnosis and appropriate management of lower respiratory tract infections in adults aged 18 and over (excluding people with COPD) after clinical assessment whether antibiotics should be prescribed. The study POC assay data could be used as an effective tool alongside NICE guidelines to prescribe antibiotics based on CRP concentration where an infection may be viral. Recent clinical studies suggest the POC test is highly effective, yielding over 80% sensitivity and over 90% specificity when identifying bacterial and viral infections in adults (NICE, 2020).
- Conditions
- Acute Respiratory Infection
- Being tested
- FebriDx Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FebriDx DeviceDevice
Patients suspected of an acute respiratory infection were tested using the FebriDx POC assay.
| Study group | Role | What they receive |
|---|---|---|
| Suspected ARI patients | Patient presenting with acute respiratory infections tested using the FebriDx POC assay. Receives: Device: FebriDx Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between FebriDx result and Clinician Decision
The level of agreement between the FebriDx classification (viral or bacterial) and the clinician's initial diagnostic impression and treatment decision (i.e. prescribe antibiotics or not).
Measured: Feb 2023
Secondary outcomes (1)
Sensitivity and Specificity of FebriDx vs.Clinical Judgement
Sensitivity (true positive rate) and specificity (true negative rate) of FebriDx in identifying bacterial or viral infections, using clinical decision as reference.
Measured: Feb 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start12 Sep 2022
- Primary completion5 Dec 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Wales
- Sponsor type
- University, hospital or other
- Collaborators
- Cwm Taf University Health Board (NHS)
- Responsible party
- Sponsor
- Investigators
- Prof Mark Williams, PhD, Study director, Chief Investigator University of South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912022
- Sponsor's protocol ID
- 306081
- Acronym
- ASPIRE I
- Status last verified
- Mar 2025
- First submitted
- 24 Feb 2022
- Last updated
- 4 Apr 2025
- 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 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Antibiotic Stewardship in Primary Care Via Point-of-care Testing (POCT) for Acute Respiratory Tract Infections
- ClinicalTrials.gov ID
- NCT06912022
- Acronym / sponsor ID
- ASPIRE I / 306081
- Conditions
- Acute Respiratory Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of South WalesUniversity, hospital or other
- Collaborators
- Cwm Taf University Health Board (NHS)
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 4 Apr 2025 (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.
The ASPIRE study is an uncontrolled observational feasibility study, and a collaboration between the University of South Wales and Cwm Taf Morgannwg University Health Board (CTMUHB). The study is based at Ysbyty Cwm Rhondda (YCR) and Keir Hardy Primary Care (KHPC) centres, where participant recruitment will take place. Study participants will be invited to provide capillary blood samples (via finger prick sampling) for testing. The principal investigators are Dr Aled Davies at YCR and Dr Shyama Velupillai at KHPC. Upon clinical assessment, and after provision of consent, participants will undergo an ARI (acute respiratory infection) POC assay. This is a dual marker immunoassay designed to detect raised levels of C-reactive protein and MxA in capillary blood. The assay uses the sensitivity of CRP and specify of MxA to aid in the differentiation of ARI's in Primary Care.
The POC assay results will be compared to the participants clinical outcomes and the physician directed treatment pathway via reviewing medical records and by contacting the patient from 14 days after their visit.
Detailed description
Antibiotic stewardship is fast becoming an essential measure to improve antibiotic prescribing by clinicians. Antibiotic stewardship not only presents a cost-effective strategy for the NHS but addressed the issue of antimicrobial resistance (AMR) and protects patients from harm caused by unnecessary antibiotic use.
The economic costs of antibiotic resistance are largely unknown, but it is anticipated that with an increased number of cases, effects to the economy could be severe. Infections and infectious diseases cost England \& Wales an estimated £30 billion a year, with many cases of acute respiratory infections (Chaplin, 2017). POC diagnostic tests in a clinical setting could give clinicians the ability to distinguish between microbial and viral infections, providing a more informed decision to antibiotic prescribing.
The purpose of this study is to safely distinguish between bacterial or viral respiratory infections in a primary care setting using "point of care" (POC) testing to provide a retrospective insight as to whether clinical assessment of an acute respiratory infection (ARI) is justified. Upon clinical assessment, the current clinical practice prescribes antibiotics based on symptoms reported by the patient and a subjective review by the GP. This results in antibiotics being prescribed from an informed decision made by the clinician, based only from patient symptoms. The use of a dual marker immunoassay could guide informed decisions based on qualitative data and degree of infection using POC testing in Primary Care.
The POC assay uses a dual marker immunoassay to differentiate between a viral and bacterial infection. C-reactive protein (CRP) is raised in the blood stream in response to inflammation. CRP can be elevated in viral infections, but generally the rise is to higher levels in bacterial infections, especially severe bacterial infections. Another blood protein, the MxA protein, is selectively increased in people with viral infections and therefore has the potential to greatly enhance the rapid distinction between viral and bacterial respiratory infections.
NICE guidance from 2014 recommends the use of CRP POC test in the diagnosis and appropriate management of lower respiratory tract infections in adults aged 18 and over (excluding people with COPD) after clinical assessment whether antibiotics should be prescribed. The study POC assay data could be used as an effective tool alongside NICE guidelines to prescribe antibiotics based on CRP concentration where an infection may be viral. Recent clinical studies suggest the POC test is highly effective, yielding over 80% sensitivity and over 90% specificity when identifying bacterial and viral infections in adults (NICE, 2020).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected ARI patients | – | Device: FebriDx DevicePatient presenting with acute respiratory infections tested using the FebriDx POC assay. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be recruited from self-referred patients attending YCR and KHPC centres with a self-suspected acute respiratory infection (ARI). The study aims to collect a minimum of 140 participants using a pragmatic sampling regime. The feasibility study will provide the data required to design and conduct a more detailed and statistically powered trial.
Key inclusion criteria (2 listed)
- Subject >18 years of age.
- Having new onset symptoms suggestive of acute respiratory infection (ARI within 7 days of seeking care: runny nose, nasal congestion, sore throat, cough, hoarse voice, softness of breath) with or without fever.
Key exclusion criteria (6 listed)
- Unable to provide informed consent.
- Undergoing end of life care.
- Immunocompromised or taking chemotherapy, oral steroids, or interferon.
- Receiving a live vaccine in the last 14 days.
- Taking antibiotics or antivirals in the last 14 days.
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 |
|---|---|---|
| FebriDx DevicePatients suspected of an acute respiratory infection were tested using the FebriDx POC assay. | Device | Suspected ARI patients |
Primary outcome
Concordance between FebriDx result and Clinician Decision
Time frame: Feb 2023
The level of agreement between the FebriDx classification (viral or bacterial) and the clinician's initial diagnostic impression and treatment decision (i.e. prescribe antibiotics or not).
1 secondary outcome
Sensitivity and Specificity of FebriDx vs.Clinical Judgement
Time frame: Feb 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- 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.
Prof Mark Williams, PhD study director
Chief Investigator University of South Wales
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Infection, run by University of South Wales at 2 sites in United Kingdom.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance between FebriDx result and Clinician Decision (time frame: Feb 2023). 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 4 Apr 2025.