跳至主要内容
临床试验/NCT07013006
NCT07013006尚未招募不适用

Retrospective Study to Assess the Evolution of MRI or CT Lesions in Treated CNS Nocardiosis

Assistance Publique - Hôpitaux de Paris13 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
13
主要终点
Percentage reduction in cerebral nocardiosis lesions

研究概览

简要总结

Nocardiosis is a rare infection caused by bacteria of the genus Nocardia spp. It primarily affects immunocompromised individuals, such as solid organ or hematopoietic stem cell transplant recipients, as well as individuals with anti-GM-CSF antibodies. The infection typically begins by inhalation, affecting the lungs, with frequent hematogenous spread to the brain and soft tissues. Cerebral involvement is present in 20 to 40% of cases, although 40% of patients remain neurologically asymptomatic.

Treatment consists of prolonged antibiotic therapy and, sometimes, surgical drainage for large or refractory abscesses. Mortality associated with cerebral involvement varies between 20 and 40%. Although radiological improvements are observed under treatment, the link between image changes and clinical prognosis remains uncertain. Regular radiological monitoring is recommended during and after treatment, although the expected evolution has not been described in the literature.

详细描述

Nocardiosis is a rare infection caused by bacteria of the genus Nocardia spp. It primarily affects immunocompromised individuals, such as solid organ or hematopoietic stem cell transplant recipients, as well as individuals with anti-GM-CSF antibodies. The infection typically begins by inhalation, affecting the lungs, with frequent hematogenous spread to the brain and soft tissues. Cerebral involvement is present in 20 to 40% of cases, although 40% of patients remain neurologically asymptomatic. Brain imaging is essential for diagnosis, with MRI often being preferred due to its sensitivity. Images often show multiple abscesses, but without sufficient specificity to differentiate nocardiosis from other pathogens. New MRI techniques could improve lesion characterization.

Treatment consists of prolonged antibiotic therapy and, sometimes, surgical drainage for large or refractory abscesses. Mortality associated with cerebral involvement varies between 20 and 40%. Although radiological improvements are observed under treatment, the link between image changes and clinical prognosis remains uncertain. Regular radiological monitoring is recommended during and after treatment, although the expected evolution has not been described in the literature.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Minor or adult patient with cerebral nocardiosis, defined by the presence of compatible clinical and radiological signs associated with the detection of Nocardia spp. in a biological sample (cerebral or extracerebral).
  • With available imaging tests:
  • All patients with 3 brain imaging tests at the 3 stages of treatment: within 2 weeks of diagnosis, upon transition to maintenance treatment (3-6 weeks after the start of treatment), and at the end of treatment (between 1 month before and 1 month after the end of antibiotic treatment). MRI scans are preferred; in the absence of MRI images, contrast-enhanced CT scans will be included.
  • OR: any patient who has undergone an MRI and a contrast-enhanced CT scan within two weeks of diagnosis, with the two tests performed within 72 hours of each other.
  • OR: any patient with a multimodal brain MRI at any time during infection, preferably within one month of diagnosis.

排除标准

  • Refusal or impossibility of information.

结局指标

主要结局

Percentage reduction in cerebral nocardiosis lesions

时间窗: 12 months

Percentage reduction in cerebral nocardiosis lesions in patients with a favorable evolution and those with an unfavorable evolution at 12 months from diagnosis.

次要结局

  • Percentage of CT brain scans suggestive of cerebral nocardiosis(12 months)
  • Description of the variation in radiological presentation of cerebral nocardiosis lesions(12 months)
  • Percentage of cerebral vasculitis lesions(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (13)

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