NCT03856528撤回不适用
Infections of the Central Nervous System - an Observational Cohort Study
University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2019年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Pathologic CT findings
研究概览
简要总结
This study is to describe the incidence of infectious meningitis and/or encephalitis, and to analyze clinical, diagnostic and treatment characteristics of patients with suspected (and subsequently verified and not verified) infection.
详细描述
The specific aims of the study include:
- To assess the incidence, the diagnostic workup, and the treatment characteristics of patients with suspected and confirmed ME.
- To examine clinical differences between patients with initially suspected and confirmed infectious Meningitis (ME) versus those with suspected but not confirmed infectious ME.
- To evaluate potentially prognostic factors for pathological CT findings (especially expanding cerebral mass lesions) in patients with suspected infectious ME.
- To identify a specific group of patients that benefit from cranial CT prior to LP.
- To examine possible complications (e.g., hematoma, postpuncture headache, cerebral herniation, ...) of lumbal punction (LP) and their correlations to pathologic signs on cranial CT.
- To compare the outcome between patients with suspected infectious ME and cranial CT prior to LP versus patients without prior cranial CT.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •All patients aged ≥18 years admitted to the University Hospital Basel with confirmed infectious meningitis and/or encephalitis as principal and/or secondary diagnosis from January 2006 to December 2021 with or without cranial CT prior to LP
- •All patients aged ≥18 years admitted to the University Hospital Basel over the same time period with suspected infectious meningitis and/or encephalitis as principal and/or secondary diagnosis with or without cranial CT
排除标准
- •Patients without suspected infectious meningitis and/or encephalitis.
- •Patients with the diagnosis of meningitis/encephalitis confirmed prior to hospital admission
- •Patients who have refused "General Consent" (i.e., written agreement of patients which allows the further use of their collected medical data for research purposes in encoded form).
结局指标
主要结局
Pathologic CT findings
时间窗: single time point assessment during hospital stay (up to 4 weeks)
assessment of number of patients with pathologic CT findings
Pathologic CT findings constituting a risk factor for herniation after performance of LP
时间窗: single time point assessment during hospital stay (up to 4 weeks)
assessment of number of patients with pathologic CT findings constituting a risk factor for herniation after performance of LP
incidence of patients with suspected and confirmed ME (number)
时间窗: single time point assessment during hospital stay (up to 4 weeks)
assessment of number of patients with suspected and confirmed ME
次要结局
- Glasgow Outcome Score(single time point assessment during hospital stay (up to 4 weeks))
- cerebral herniation (number)(single time point assessment during hospital stay (up to 4 weeks))
- Intensive Care Delirium Screening Checklist (ICDSC)(single time point assessment during hospital stay (up to 4 weeks))
- hematoma (number)(single time point assessment during hospital stay (up to 4 weeks))
- pathological CT findings (number)(single time point assessment at hospitalisation (Day1))
- postpuncture headache (number)(single time point assessment during hospital stay (up to 4 weeks))
- kind of medication(single time point assessment during hospital stay (up to 4 weeks))
- Death during hospital stay(single time point assessment during hospital stay (up to 4 weeks))
- Return to premorbid functional baseline(single time point assessment during hospital stay (up to 4 weeks))
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Neurological Complication of Infective Endocarditis: A Prospective Multi-site Cohort StudyEndocarditis, BacterialAneurysm, Intracranial MycoticNCT05152225the Jeunes en Neuroradiologie Interventionnelle (JENI) research group200
Unknown
不适用
Singapore Neurologic Infections ProgramCentral Nervous System InfectionsNCT02017665Singapore General Hospital400
尚未招募
Unknown
Commoness of Brain infections during and after COVID 19 eraCTRI/2024/04/066493Self sponsored
尚未招募
不适用
Establishment of Prevention and Control System of Central Nervous System InfectionCentral Nervous System (CNS) InfectionMeningitisEncephalitisNCT04722328Xuanwu Hospital, Beijing715
Unknown
不适用
Aseptic Meningoencephalitis in SloveniaAseptic MeningitisNCT02328469University Medical Centre Ljubljana800