NL-OMON50405已完成不适用
Community-Acquired Pneumonia: lytA TArgeted real-time quantitative polymerase chaIN reaction for improved detection of pneumococci. - qPCR in community-acquired pneumonia, CAPTAI
oordwest Ziekenhuisgroep0 个研究点目标入组 980 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 980
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •-Age 18 years or above;
- •-Presentation at the emergency department (ED);
- •-Working diagnosis of CAP at the ED with the presence of at least two of the
- •following criteria:
- •1. New or worsened coughing;
- •2. Production of purulent sputum or change in sputum colour;
- •3. Temperature >38.0 *C or <=36.0 *C (tympanic);
- •4. Auscultatory findings consistent with pneumonia, including rales, evidence
- •of pulmonary consolidation (dullness on percussion, bronchial breath sounds,
- •or egophony), or both;
- •5. White blood cell count of >10x10^9 cells/L or <4x10^9 cells/L or >15%
- •6. C-reactive protein level >=30mg/L;
- •7. Dyspnea, tachypnea, (>20 breaths per minute), or hypoxemia (arterial pO2
- •<60mmHg or peripheral O2 saturation <90%).
- •-New consolidation(s) on the chest radiograph or computed tomography (CT);
- •-No other explanation for the signs and symptoms;Control group 1 - Related
- •-Being aged 18 years or above;
- •-Close relative of the patient: relative defined as living in the same house as
- •the CAP patient or daily contact;
- •-Is at the hospital at the moment of inclusion of the CAP patient or is willing
- •to come for testing within 7 days.Control group 2 - Unrelated healthy
- •individuals
- •-Being aged 18 years or above;
- •-Subject with a preoperative appointment with the anaesthiologist for a planned
- •surgical procedure;
- •-Age, gender and time matched to an included CAP patient.Control group 3 -
- •Patients with stable COPD
- •-Being aged 18 years or above;
- •-Diagnosis of COPD confirmed with spirometry (GOLD criteria 2017)(76).Control
- •group 4 - Patients with exacerbation of COPD
- •-Being aged 18 years or above;
- •-Diagnosis of COPD confirmed with spirometry (GOLD criteria 2017)(76);
- •-Diagnosis of exacerbation of COPD: defined as an acute event characterised by
- •a worsening of the patient*s respiratory symptoms that is beyond normal
- •day-to-day variations and leads to a change in medication (76);
排除标准
- •In general:
- •-Pneumonia in the last month or pneumococcal pneumonia (proven by usual
- •diagnostics) in the last three months;
- •-Not capable of understanding information needed to sign informed
- •consent;Patients:
- •-Was included in the present study group before;
- •-Aspiration pneumonia;
- •-Hospitalisation for two or more days in the last 14 days;
- •-History of cystic fibrosis.For all control groups:
- •-Fits inclusion criteria for patient group;
- •-Present or recent hospitalisation (14 days);
- •-Use of antibiotics in the last 14 days, including maintenance antibiotic
- •therapy.Control group 1 and 2 - Related healthy controls and unrelated healthy
- •individuals
- •-Active infectious respiratory complaints defined as defined as two or more
- •respiratory symptoms (cough, nasal congestion, runny nose, sore throat or
- •-Temperature >38.0 *C
- •-Chronic pulmonary disease: COPD, asthma, cystic fibrosis, bronchiectasis;
- •Control group 3 - Patients with stable COPD
- •-Temperature >38.0 *C;
- •-Stable disease;
- •-Recent exacerbation (<1 month) defined as increased respiratory symptoms with
- •need of antibiotic and/or corticosteroid therapy.Control group 4 - Patients
- •with exacerbation of COPD
- •-Current pneumonia;
- •-Recent exacerbation (<1 month) defined as increased respiratory symptoms with
- •need of antibiotic and/or corticosteroid therapy.
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