Procalcitonin-guided Treatment Regarding Antibiotic Use for Acute COPD Exacerbations: a Prospective Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 693
- 试验地点
- 11
- 主要终点
- Treatment failure
研究概览
简要总结
This study the investigators will examine whether procalcitonin-guided treatment regarding antibiotic therapy is non-inferior to usual care in patients who are admitted because of an acute COPD exacerbation when it comes to treatment failure on day 30.
详细描述
Chronic obstructive pulmonary disease (COPD) is a prevalent disease, worldwide, and in the Netherlands with approximately 600.000 patients. COPD is currently the 3rd leading cause of death worldwide and is also a leading cause of disability-adjusted life years. Given the contribution of exacerbations both to loss in quality of life and to health-care costs, it is of paramount importance to improve the current treatment of exacerbations.
Pulmonary physicians are well aware of overuse of antibiotics, but lack the tools to decide which medication to give in the clinical setting. Biomarkers may aid towards a more personalized treatment of acute COPD exacerbations (AECOPD). Procalcitonin (PCT), the precursor of calcitonin, is released in response to a bacterial infection by many tissues within 6-12 hours after the onset of infection, while the concentration is only minimally raised in viral infections, making it a relative specific diagnostic tool for bacterial infection. Several trials have shown a reduction in antibiotic consumption in AECOPD when using a PCT-guided treatment algorithm. Recent systematic reviews concluded that appropriately powered trials are lacking to confirm that clinical outcomes are comparable with usual care.
In this study the investigators will examine whether a PCT-guided treatment regarding antibiotic therapy is non-inferior to usual care in patients who are admitted because of an acute COPD exacerbation when it comes to treatment failure on day 30.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD, according to GOLD 2018 definition
- •Indication for hospitalization because of acute severe exacerbation of COPD, as defined by GOLD 2018 and modified Anthonisen criteria
- •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)
- •Post-bronchodilator FEV1/FVC < 0,70 and FEV1% < 80%pred. within last 5 years
- •At least 40 years
- •Smokers or ex-smokers with > 10 packyears
- •Written informed consent
- •Start of symptoms no more than 7 days before admission
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.
- •Patients with COPD , with or without a history of asthma (in childhood or as an adolescent) will NOT be excluded/are allowed to participate.
- •Patients with Asthma/COPD overlap syndrome (with current asthma AND COPD) will NOT be excluded/are allowed to participate.
- •Clinically relevant heart failure or myocardial ischemia
- •Chronic use of immunosuppressants, including prednisolone (a prednisone equivalent of 10mg or less is allowed/is NOT an exclusion criterion)
- •Known bronchiectasis as a 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)
研究组 & 干预措施
Usual care
Patients randomized to this arm will receive antibiotic treatment based on the physician's decision.
干预措施: Physician's decision (Other)
PCT-guided treatment
Patients randomized to this arm will only receive antibiotic treatment when the procalcitonin concentration is > 0.25ug/L.
干预措施: Procalcitonin (Diagnostic Test)
结局指标
主要结局
Treatment failure
时间窗: 30 days
Treatment failure is defined as disease-related mortality, need for endotracheal intubation or vasopressors, renal failure (defined as Kidney Disease: Improving Global Outcomes (KDIGO) stage 3 - new renal replacement therapy, tripling of baseline creatinine, or serum creatinine \> or = 350 umol/L), lung abcess/empyema, development of pneumonia or rehospitalization within 30 days after inclusion.
次要结局
- Sputum Color Chart(On day 1 participants use a sputum color chart to report their current sputum color. This can be Mucoid, Mucopurulent (pale yellow/pale green), Purulent dark yellow, Purulent dark green)
- Re-exacerbation(30 days)
- CAT(change between baseline and day 30)
- EQ-5D-5L(change between baseline and day 30)
- Decision to start antibiotic therapy after an initial opposite decision (after 48 hours)(30 days)
- Incomplete resolution of the clinical signs and symptoms(day 30)
- iMCQ(30 days)
- Cumulative antibiotic consumption(30 days)
- Cumulative prednisolone consumption(30 days)
- Length of hospitalization(up to 30 days)
- Non-invasive ventilation after 72 hours of admission(30 days)
- Time to complete resoluation of symptoms(30 days)
- Modified Anthonisen criteria(day 10)
- Side effects of antibiotic treatment(30 days)
- EXACT respiratory questionnaire(day 30)
- EQ-5D-5L(day 10)
- Incomplete resolution of the clinical signs and symptoms(change between baseline and after 30 days)
- Modified Anthonisen criteria(baseline)
- Modified Anthonisen criteria(day 3)
- Modified Anthonisen criteria(day 5)
- EXACT respiratory questionnaire(change between baseline and after 30 days)
- EXACT respiratory questionnaire(baseline)
- EXACT respiratory questionnaire(day 10)
- CAT(baseline)
- CAT(day 10)
- CAT(day 30)
- EQ-5D-5L(baseline)
- EQ-5D-5L(day 30)
研究者
Menno M. van der Eerden
Principal investigator and Pulmonologist
Erasmus Medical Center