ASPIRE II. Supporting Antibiotic Stewardship in Primary Care Via POCT

NCT06981130 | Completed

• 1 other identifier: 322984
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 3

Brief Summary

Acute Respiratory Infections (ARIs) are a major contributor to antibiotic resistance, largely due to the over prescription of antibiotics driven by the subjective nature of clinical assessment. The ASPIRE II study aims to evaluate whether a Point-of-Care (POC) diagnostic test, utilising C-reactive protein (CRP) and Myxovirus resistance protein A (MxA) biomarkers to differentiate between viral and bacterial infections can support clinical decision-making and serve as an effective antimicrobial stewardship tool.

Conditions

Acute Respiratory Infection

Keywords

ARI; MxA; CRP; NICE; POC; Primary Care

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, to prescribe antibiotics or not.

  End of recruitment period.

Secondary Outcomes (1)

• Sensitivity and Specificity of FebriDx vs. Clinical Judgement

  End of recruitment period .

Study Arms (1)

Patients Suspected with Acute Respiratory Infection

OTHER

Self-referred patients presenting ARI symptoms that have met the study inclusion criteria and have been recruited to the study.

Device: FebriDx Point of Care Test

Interventions

FebriDx Point of Care Test DEVICE

Patients self-referring to their GP practice with symptoms of acute respiratory infection (ARI) will receive the FebriDx point-of-care test during their clinical consultation.

Patients Suspected with Acute Respiratory Infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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, shortness 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 have symptoms lasting more than 7 days.

Sponsors & Collaborators

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

Study Sites (3)

Kier Hardie Practice 3

Merthyr Tydfil, Rhondda Cynon Taff, United Kingdom

Location

Oaktree Surgery

Bridgend, United Kingdom

Location

Meddygfa Glan Cynon Surgery

Mountain Ash, United Kingdom

Location

Study Design

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

Model Details: This study follows a single-group assignment model in which all participants presenting to general practice with symptoms of acute respiratory infection (ARI) undergo testing with a Point-of-Care (PoC) diagnostic device. The device measures C-reactive protein (CRP) and Myxovirus resistance protein A (MxA) to help differentiate between viral and bacterial infections. The intervention is applied uniformly, and outcomes such as test performance, diagnostic accuracy, clinician decision-making, and antibiotic prescribing behaviour are monitored prospectively. No randomisation or control arm is included, as the primary objective is to evaluate real-world clinical utility and diagnostic performance in a standard care setting.

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 20, 2025
• Study Start: April 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)