ISRCTN24346473已完成未知
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: a two-arm individually randomised controlled trial
Cardiff University (UK)0 个研究点目标入组 653 人开始时间: 2014年8月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 653
研究概览
简要总结
2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28969667 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31291514 (added 26/07/2019) 2020 results in https://pubmed.ncbi.nlm.nih.gov/32202490/ (added 24/03/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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 patient's baseline dyspnoea, cough and/or sputum that is beyond normal day-to-day variations, is acute in onset and may warrant a change in regular medication?
- •5. The exacerbation has lasted for at least 24 hours but equal to or less than 21 days
- •6. Are able to attend the GP surgery
- •7. Are able to provide informed consent and complete study procedures.
排除标准
- •Current exclusion criteria as of 21/02/2017:
- •1. The responsible GP feels urgent referral to hospital is necessary
- •2. Severe illness (e.g. suspected pneumonia, tachypnoea >30 breaths per minute, respiratory failure)
- •3. Concurrent infection at another site (e.g. UTI, Cellulitis) that is likely to produce a systemic response
- •4. Past history of respiratory failure or mechanical ventilation
- •5. Currently on antibiotics or has had antibiotics for this acute exacerbation of COPD
- •6. Active inflammatory condition (e.g. Flare up of rheumatoid arthritis, gout or polymyalgia rheumatica)
- •7. Has cystic fibrosis, a current tracheostomy or bronchiectasis
- •8. Immunocompromised (e.g. AIDS, taking systemic immunosuppressive therapy or receiving anti-cancer radiotherapy or chemotherapy)
- •9. Currently pregnant
- •10. Previously been recruited into the PACE study
- •Previous exclusion criteria:
- •1. Very severe COPD (GOLD stage 4; FEV1 < 30% predicted)
- •2. Coexisting infection (i.e. urinary tract infection, cellulitis)
- •3. Suspected pneumonia or requiring immediate hospital admission
- •4. History of requiring mechanical ventilation for an AECOPD
- •5. Active chronic inflammatory condition (i.e. rheumatoid arthritis)
- •6. Currently already taking high dose oral steroids (equivalent to 60mg per day or more of prednisolone)
- •7. Has taken oral antibiotics in previous four weeks
- •8. Life limiting malignancy
- •9. Cystic fibrosis
- •10. Current tracheotomy
- •11. Bronchiectasis of any aetiology other than COPD
- •12. Previously been recruited into the PACE study
研究者
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