NCT03315403已完成不适用
Community-Acquired Pneumonia: lytA TArgeted Real Time Quantitative Polymerase chaIN Reaction for Improved Detection of Pneumococci (CAPTAIN)
Medical Center Alkmaar2 个研究点 分布在 1 个国家目标入组 922 人开始时间: 2018年4月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 922
- 试验地点
- 2
- 主要终点
- Pneumococcal pneumonia with usual tests
研究概览
简要总结
The purpose of this study is to evaluate the added diagnostic value of a quantitative polymerase chain reaction targeting the lytA gene in detecting pneumococci in patients with community-acquired pneumonia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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:
- •New or worsened coughing;
- •Production of purulent sputum or change in sputum colour;
- •Temperature >38.0 ⁰C or ≤36.0 ⁰C (tympanic);
- •Auscultatory findings consistent with pneumonia, including rales, evidence of pulmonary consolidation (dullness on percussion, bronchial breath sounds, rales, or egophony), or both;
- •White blood cell count of >10x10^9 cells/L or <4x10^9 cells/L or >15% bands;
- •C-reactive protein level ≥30mg/L;
- •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 controls
- •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 matched to a included CAP patient (+-10 years);
- •Time matched to a included CAP patient (up to 14 days after inclusion of the CAP patient);
- •Gender matched to a 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);
- •Stable disease.
- •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).
- •Presentation at emergency department with the suspicion of an exacerbation.
排除标准
- •In general:
- •Recent pneumonia (< 1 month) or pneumonia in last 3 months with known pneumococcal aetiology with one of current diagnostics;
- •Was included in the study group before;
- •Not capable of understanding information needed to sign informed consent.
- •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);
- •Fits inclusion criteria for patient group;
- •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 sneezes);
- •Temperature >38.0 ⁰C;
- •Fits inclusion criteria for control group 3 or 4;
- •Chronic pulmonary disease: COPD, asthma, cystic fibrosis, bronchiectasis.
- •Control group 3 - Patients with stable COPD
- •Temperature >38.0 ⁰C;
- •Stable disease;
- •Fits inclusion criteria for control group 4;
- •Recent exacerbation (<1 month) defined as increased respiratory symptoms with need of antibiotic and/or corticosteroid therapy;
- •History of cystic fibrosis.
- •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;
- •Fits inclusion criteria for control group 3;
- •History of cystic fibrosis.
结局指标
主要结局
Pneumococcal pneumonia with usual tests
时间窗: 1 day, day of inclusion
Occurrence of pneumococcal pneumonia proven by at least one of the routine microbiological tests (urine antigen test, blood culture and/or sputum culture). The difference between outcome measure 1 and 2 is the added diagnostic value.
qPCR diagnosed pneumococcal pneumonia
时间窗: 1 day, day of inclusion
Occurrence of qPCR proven pneumococcal pneumonia (CAP with S. pneumoniae detected by qPCR in at least one of the samples with a positive lytA qPCR and a DNA copy number above the determined cut-off value) using the cut-off value in at least one of the specimens at inclusion. The cut-off value will be determined in this study, see secondary objective.
次要结局
- Number of DNA copies of S. pneumoniae in all lytA qPCR positive study subjects(1 day, day of inclusion)
- CURB-65 scores(1 day, day of inclusion)
- Occurrence of positive lytA qPCR at 30 days after inclusion in CAP patients(30 days)
- Procalcitonin(1 day, day of inclusion)
研究者
W.G.Boersma
MD. PhD. Pulmonologist
Medical Center Alkmaar
研究点 (2)
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