Extrait

Background and study aims Chronic obstructive pulmonary disease (COPD) is a group of lung conditions that cause breathing difficulties. People with COPD often experience sudden worsening of symptoms, known as acute exacerbations of COPD (AECOPD). Most patients presenting with AECOPD in primary care are prescribed an antibiotic, which may not always be appropriate and may cause harm. Current antibiotic prescribing recommendations for general practitioners (GPs) are generally based on symptoms alone (Anthonisen criteria). However, these symptoms are subjective and are not enough to predict which patients can safely be managed without antibiotics. C-reactive protein (CRP) is a protein found in the blood that can be rapidly measured at the point of care and may predict benefit from antibiotic treatment in AECOPD. Point of care tests (POCTs) for acute infections are being promoted to reduce inappropriate prescribing, reduce antibiotic resistance and to improve patient outcomes, but the benefits of CRP POCT in conjunction with clinical examination have not yet been tested for AECOPD in primary care. The aim of this study is to find out whether the addition of a CRP POCT (with training on test use and advice on interpretation) to usual care for managing an AECOPD leads to a reduction in antibiotic consumption for AECOPD without negatively impacting on COPD health status, compared with usual care alone. Who can participate? Adults over the age of 40 with an acute exacerbation of COPD that has lasted between 24 hours to 21 days What does the study involve? Participants are randomly allocated to either clinical management based on usual care, or usual care with the addition of a CRP POCT. The clinician records the number of days the participant reports having symptoms from the acute exacerbation, their medical history, and clinical examination results. A sputum sample (when participants are able to produce sputum) and throat swab samples (using charcoal swabs) are obtained from the participant. The clinicians assess and record the colour of the participant’s sputum. Participants are asked to complete questionnaires. The CRP test results are recorded for those allocated to care with the addition of the CRP POCT. Antibiotic prescribing and other management decisions are recorded for all participants. The trial team aim to telephone all participants one week and two weeks later to collect information on their medication usage during that time and also to obtain their responses to questionnaires. Participants are invited to return to the surgery for a face-to-face consultation after four weeks. The following data are collected at the week 4 appointment: medication consumption, adverse effects, time off paid work, diagnosis of pneumonia since the first appointment, any further CRP tests since the first appointment, healthcare consultations. Sputum (where possible) and throat swab samples are obtained from the participant and the colour of the sputum is assessed. Participants are asked to complete questionnaires. More questionnaires are posted to participants for completion and return after 6 months. What are the possible benefits and risks of participating? Possible benefits include avoiding unnecessary antibiotics and therefore any adverse effects from taking them, using antibiotics appropriately when they are likely to be beneficial, closer monitoring and follow-up by the GP, and developing awareness around the prudent use of antibiotics for AECPOD and in general for the patients and GPs. Potential risks include the GP withholding antibiotic treatment from participants with a low CRP value. However, all participating sites are provided with information on current best practice. The GPs would be free to use antibiotics if they think this to be appropriate regardless of CRP values. Many cases of acute exacerbations are routinely treated without antibiotics at the moment, especially when the GP feels that the exacerbation is not likely to be caused by bacteria. The CRP test could help in making better decisions about antibiotic prescriptions. Where is the study run from? GP practices in Wales, Thames Valley, London, Eastern CRN and North West Coast CRN (UK) When is the study starting and how long is it expected to run for? November 2014 to July 2017 Who is funding the study? The National Institute of Health Research (NIHR) Health Technology Assessment (HTA) programme Who is the main contact? Prof. Chris Butler [email protected]

Critère d'inclusion

• Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)

Liens

• ictrp
• isrctn