NCT05380193已完成不适用
Serotype Distribution in Hospitalized Adult With Pneumococcal Community Acquired Pneumonia in France
Institut National de la Santé Et de la Recherche Médicale, France5 个研究点 分布在 1 个国家目标入组 1,017 人开始时间: 2022年5月9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
- 1,017
- 试验地点
- 5
- 主要终点
- proportions of S. pneumoniae serotypes included in PCV20
研究概览
简要总结
CAP'Hospi is an observational, multicentric study in France which primary objective is to describe the proportion of Community Acquired Pneumonia due to serotypes included in PCV20 among adults hospitalized for CAP
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
- 否
入选标准
- •Adults 18 years of age or older
- •Admission to hospital for at least 24 hours
- •Suspicion of community-acquired pneumonia at admission defined as the association of: Radiologic findings consistent with pneumonia (eg, pleural effusion, increased pulmonary density due to infection and/or alveolar infiltrates [multilobar, lobar, or segmental] containing air bronchograms), AND The presence of ≥2 of the following signs or symptoms: Fever (oral temperature >38°C or tympanic temperature >38.5°C) in the 24 hours preceding admission; Hypothermia (<35.5°C measured by a healthcare provider) in the 24 hours preceding admission ; Chills or rigors ; Pleuritic chest pain ; New or worsening cough ; Sputum production ; Dyspnea (shortness of breath); Tachypnea (respiratory rate >20/min) ; Malaise ; Abnormal auscultatory findings suggestive of pneumonia (rales or evidence of pulmonary consolidation)
- •Written informed consent from the patient
排除标准
- •Suspicion of tuberculosis
- •Individuals placed under judicial protection
- •Individuals who refuse the transfer of biological samples to the USA
- •Patient developing signs and symptoms of pneumonia after having been hospitalized for 48 hours or more
结局指标
主要结局
proportions of S. pneumoniae serotypes included in PCV20
时间窗: 2 years
The proportion will be determined by UAD assay and/or culture from any sites overall and by age and risk group among adults hospitalized with CAP
次要结局
- Patients hospital stay by serotype groups(2 years)
- proportion of serotypes of S. pneumoniae by group(2 years)
- Patients hospital trajectories(2 years)
- The proportion of patients who required re-hospitalization following hospital discharge(2 years)
- Prevalence of different bacterial and viral causes of hospitalized CAP(2 years)
- The proportion of patients with a severe CAP(2 years)
研究者
研究点 (5)
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