PACE, Version 1.0
Research type
Research Study
Full title
Primary care use of a C-Reactive Protein (CRP) Point of Care Test (POCT) to help target antibiotic prescribing to patients with Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) who are most likely to benefit
IRAS ID
159928
Contact name
Christopher Butler
Contact email
Sponsor organisation
Cardiff University
Research summary
About a million people in the UK are diagnosed with COPD. People with COPD often experience sudden worsening of symptoms, known as acute exacerbations (AECOPDs). AECOPDs are usually treated with antibiotics, although not all benefit from this. Frequent antibiotics can generate bacterial-populations in the lungs and elsewhere that becomes resistant to antibiotics. This makes subsequent AECOPDs harder to treat.
C-reactive protein (CRP) in blood can quickly be measured from a finger prick ‘point-of-care test' (POCT). When CRP is low, patients are unlikely to benefit from antibiotics. The PACE study will determine whether GP use of a simple, rapid, one-step CRP-POCT in addition to clinical assessment leads to improved antibiotic prescribing in AECOPD. We will recruit 650 patients with AECOPD. Potentially eligible patients will be sent study information a priory, to allow patients to become informed and consider participating before they become unwell. Those who get an AECOPD and provide consent will be randomly assigned to one of the two management plans: 1) current best practice with the addition of a CRP POCT, or 2) current best practice. Antibiotic prescribing decision will be based on clinical judgment, not just the CRP test result. Patients with very severe COPD will not be eligible.
PACE will determine whether adding the CRP POCT to current best practice reduces antibiotic consumption during the first four weeks, without negatively impacting on health related quality of life (HRQOL). We will also assess if CRP-POCT has an impact on bacterial-resistance, symptoms, HRQOL, adverse-effects, pneumonia, and re-consultations rates over the first 4 weeks. We will assess whether the cost of the test can be justified against any improvements in patient care and potential reduction in antibiotic resistance. Interviews with approximately 20 patients and 20 clinicians will gather in-depth feedback on the test use. This study is funded by NIHR.REC name
Wales REC 6
REC reference
14/WA/1106
Date of REC Opinion
15 Sep 2014
REC opinion
Further Information Favourable Opinion