NL-OMON55985招募中不适用
Procalcitonin-guided treatment regarding antibiotic use for acute COPD exacerbations: a prospective randomised controlled trial - PRECISION study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 693
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •- COPD, according to GOLD 2018 definition
- •- Hospitalization because of severe acute exacerbation of COPD
- •- Post-bronchodilator FEV1/FVC < 0,70 and FEV1% < 80%pred. within last 5 years
- •or a lung function within 2 months after the index admission that meets these
- •- At least 40 years of age
- •- Smokers or ex-smokers with > 10 packyears
- •- Written informed consent
- •- Start of symptoms no more than 7 days before admission
- •- Presence of at least 2 major symptoms of the modified Anthonisen
- •criteria (acute deterioration
- •in sputum volume, sputum purulence and dyspnea) or the presence of 1
- •major symptom and 1
- •minor symptom (coughing, wheeze, nasal discharge, sore throat, fever)
排除标准
- •- Indication for ICU and or non-invasive ventilation < 72h of admission
- •- Pneumonia, radiologically confirmed
- •- Infection at another site and/or sepsis according to the SIRS criteria
- •(with tachycardia and
- •tachypnea not being caused by the exacerbation).
- •- COPD before age 40.
- •- Asthma, without presence of COPD.
- •o Patients with COPD , with or without a history of asthma (in
- •childhood or as an adolescent)
- •will NOT be excluded.
- •o Patients with Asthma/COPD overlap syndrome (with current asthma AND
- •COPD) will NOT
- •be excluded.
- •- Clinically relevant heart failure or myocardial ischemia
- •- Chronic use of immunosuppressants, including prednisolone (a prednisolone
- •equivalent of 10mg or less is allowed/will NOT be excluded)
- •- Known bronchiectasis as primary diagnosis
- •- Colonisation with Pseudomonas spp. or other micro-organisms in recent
- •cultures (last 60 days) not susceptible to amoxicillin-clavulanic acid
- •- Pregnancy
- •- Recent exacerbation (last 28 days)
研究者
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