ASPIRE I: Supporting Antibiotic Stewardship in Primary Care Via POCT

NCT06912022 | Completed

• 1 other identifier: 306081
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 2

Brief 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). 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.

Conditions

Acute Respiratory Infection

Outcome Measures

Primary Outcomes (1)

• 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).

  Feb 2023

Secondary Outcomes (1)

• Sensitivity and Specificity of FebriDx vs.Clinical Judgement

  Feb 2023

Study Arms (1)

Suspected ARI patients

Patient presenting with acute respiratory infections tested using the FebriDx POC assay.

Device: FebriDx Device

Interventions

FebriDx Device DEVICE

Patients suspected of an acute respiratory infection were tested using the FebriDx POC assay.

Suspected ARI patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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\*.

Sponsors & Collaborators

• University of South Wales: lead
• Cwm Taf University Health Board (NHS): collaborator

Study Sites (2)

Keir Hardie Practice 3

Cardiff, United Kingdom

Location

Ysbyty Cwm Rhondda

Cardiff, United Kingdom

Location

Study Officials

• Prof Mark Williams, PhD

  Chief Investigator University of South Wales

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: April 4, 2025
• Study Start: September 12, 2022
• Primary Completion: December 5, 2022
• Study Completion: January 1, 2023
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)