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

Pas encore traduit Pas encore traduit
Auteurs
Catégorie Primary study
Registry of TrialsISRCTN registry
Year 2014
INTERVENTION: Current interventions as of 21/02/2017: PACE will assess the use of a CRP POCT to guide antibiotic treatment decisions for patients presenting in primary care with AECOPD. Patients randomised to the intervention arm will have a CRP POCT at every consultation for AECOPD that occurs in the four weeks following randomisation. Control patients will not have a CRP POCT (as part of this study) at any time during their participation. Previous interventions: PACE will assess use of a C‐reactive protein (CRP) point‐of‐care test (POCT) to guide antibiotic treatment decisions for patients presenting in primary care with AECOPD. Participants will be allocated to a usual clinical care or an intervention arm. Patients randomised to the intervention arm will have a CRP test at every consultation for AECOPD that occurs in the four weeks following randomisation. Control patients will not have a CRP test (as part of this study) at any time during their participation. The CRP POCT is developed by Alere. The test requires 1.5ìl of capillary blood (finger prick sample) and takes less than 4 minutes to provide a quantitative result. CONDITION: Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) ; Respiratory ; Chronic obstructive pulmonary disease PRIMARY OUTCOME: Current primary outcome measures as of 21/02/2017:; The PACE study has co‐primary outcomes: ; 1. Antibiotic consumption (any consumption of antibiotics for AECOPD vs. no consumption of antibiotics for AECOPD) within four weeks post‐randomisation; 2. Recovery in terms of COPD health status, assessed using the clinical COPD questionnaire (CCQ) total scores at two weeks post randomisation; ; Previous primary outcome measures:; This study is based on two co‐primary outcomes:; 1. Antibiotic consumption at any point during the four weeks post‐randomisation, measured using telephone interviews at one‐week and two‐weeks and face‐to‐face interview at four‐weeks; 2. Patient‐reported health‐related quality of life (HRQoL) measured by the Chronic Respiratory Questionnaire Self‐Administered Standardised (CRQ‐SAS) via telephone interview at two‐weeks SECONDARY OUTCOME: Current secondary outcome measures as of 21/02/2017:; 1. Prevalence of potentially pathogenic bacteria (incl. S.pneumoniae, H.spp and Enterobacteriacae) and the proportion of bacteria that are resistant, cultured from sputum at 4 weeks post randomisation; 2. Prevalence of commensal organisms and the proportion of bacteria that are resistant, cultured from throat swabs at 4 weeks post randomisation; 3. COPD health status over time, measured using the CCQ total score measured at weeks 1, 2 and 4 post randomisation; 4. CCQ symptoms domain at weeks 1, 2, and 4 post randomisation; 5. CCQ function state domain at weeks 1, 2, and 4 post randomisation; 6. CCQ mental state domain at weeks 1, 2, and 4 post randomisation; 7. Total antibiotic consumption (number of days antibiotics consumed for AECOPD/any reason) during first 4 weeks post randomisation; 8. Health utility, measured using the EuroQol‐5D (EQ‐5D) at weeks 1, 2 and 4 and at month 6 post randomisation ; 9. All cause antibiotic consumption during the first four weeks post randomisation; 10. Antibiotic prescribing at the index consultation ; 11. Antibiotic prescribing during the first four weeks post randomisation; 12. Use of other COPD treatments including oral steroids during the first four weeks post randomisation; 13. Adverse effects potentially attributable to antibiotics prescribed for the exacerbation during the first four weeks post randomisation; 14. Primary and secondary care consultations, including hospitalisations at week 4 and month 6; 15. Costs (total NHS cost) and cost‐effectiveness at month 6; 16. Incidence of pneumonia, measured by patient and GP report at week 4 and month 6; 17. Disease‐specific health‐related quality of life over time, measured using CRQ‐SAS (dyspnoea, fatigue, emotion function, mastery and total scores) at month 6; ; Previous secondary outcome measures:; 1. Prevalence of significant antibiotic resistant organisms (including Streptococcus spp., H. influenzae and parainfluenzae and Enterobacteriaceae) cultured from sputum or throat swab at 4 weeks; 2. Disease‐specific health‐related quality of life over time measured using CRQ‐SAS (measured at weeks 1, 2 and 4); 3. Health utility measured using the EuroQol‐5D (EQ‐5D) (measured at weeks 1, 2 and 4); 4. Antibiotic prescribing at the index consultation; 5. Use of other COPD treatments including oral steroids (measured at weeks 1, 2 and 4); 6. Adverse effects potentially attributable to antibiotics prescribed for their exacerbation (nausea, vomiting, diarrhoea, thrush, and rash) (measured at weeks 1, 2 and 4); 7. Primary and secondary care consultations, including hospitalisations (measured at month 6); 8. Costs (total NHS cost) and cost‐effectiveness (measured at month 6); 9. Incidence of pneumonia (measured by patient and GP report at week 4 and month 6) INCLUSION CRITERIA: Current inclusion criteria as of 21/02/2017: 1. Has a current acute exacerbation [presenting with at least one of the following: Increased dyspnoea, increased sputum volume, increased sputum purulence] that has lasted for at least 24 hours and no longer than 21 days 2. Diagnosis of COPD in clinical record/on COPD Practice register 3. Age 40 years or more 4. Able to provide informed consent 5. Patient should be able to provide the primary outcome data at 2 and 4 weeks within the expected windows Previous INCLUSION CRITERIA: 1. Adults aged 40 2. Spirometry confirmed (at any time point prior to admission) COPD (post bronchodilator FEV1/FVC < 0.7) 3. Patients with mild, moderate and severe disease: that is FEV1 of more than 30% of the predicted value as indicated by the age and the height of the person (GOLD stage 1‐3) 4. Have a current AECOPD, defined as, ?an event in the natural course of the disease characterized by a change in the
Epistemonikos ID: f61f10273e443e28f21197f2fdbde6a746c5078f
First added on: Aug 23, 2024