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临床试验/NCT05636254
NCT05636254招募中不适用

Diagnostic Accuracy of Imaging Findings in Tubercular Meningitis/Spinal Tubercular Arachnoiditis and Correlation With Outcomes in Patients With Tubercular Meningitis, Spinal Tubercular Arachnoiditis

All India Institute of Medical Sciences, New Delhi1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年1月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
Sensitivity and specificity of sulcal tuberculomas in the diagnosis of tubercular meningitis

研究概览

简要总结

The goal of this Diagnostic accuracy study is

  • To study sensitivity and specificity of sulcal tuberculomas in the diagnosis of tubercular meningitis and
  • To study the correlation of imaging findings in tubercular meningitis and spinal tubercular arachnoiditis with clinical outcomes after completion of therapy
  • Secondary objectives
  • To study the proportion of patients having clinical or imaging features of spinal tubercular arachnoiditis
  • To study the factors determining outcomes in patients with spinal tubercular arachnoiditis
  • To study the treatment trends in patients with spinal tubercular arachnoiditis

The investigators will include [study Population] Patients with chronic meningitis as per criteria listed below

  • Chronic meningitis : Case definition
  • Headache with or without fever, nuchal stiffness and systemic symptoms AND
  • CSF suggestive of meningitis Pleocytosis (>20 cells per μL) with lymphocyte predominance (>50%) OR Protein concentration greater than age-specific normal value; especially >1•0 g/L OR Glucose concentration less than 60% of concentration in blood OR MRI suggestive of meningeal enhancement on contrast enhanced T1 sequences AND
  • Deemed by the treating physician that the syndrome is consistent with chronic meningitis
  • Patients who are positive for antibodies to HIV and pregnant females will also be included.
  • Willing to undergo periodic assessment clinically and with MRI as per clinical condition demands.

The sensitivity and specificity of the finding of sulcal tuberculomas will be compared to the reference standard diagnostic criteria for the diagnosis of TB meningitis.

详细描述

Methodology of the study Study design:Ambispective cohort study; Observational study; Diagnostic accuracy study

Sample size: All consecutive patients in the database will be included in the retrospective study and all new patients registered in the neurology OPD and admitted in the Neurology or General Medicine or Geriatric medicine or Medical oncology wards will be included in the prospective arm

Expecting a sensitivity of 70% of sulcal tuberculomas in tubercular meningitis with a range of 60 to 80, the investigators expect (4*70*30) /10*10=84 patients Expecting sulcal tuberculomas to have a specificity of 80%, with a range of 70 to 90%, the investigators expect (4*80*20)/10*10=64 patients Expecting a 70% prevalence of tubercular meningitis amongst patients with chronic meningitis, sample size of atleast 120 patients (70% of 120=84).

Subjects:

  • Study Population: Patients with chronic meningitis as per criteria described
  • Inclusion criteria

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Not willing to provide consent

结局指标

主要结局

Sensitivity and specificity of sulcal tuberculomas in the diagnosis of tubercular meningitis

时间窗: Day 1 of diagnosis or imaging acquisition

Sensitivity and specificity of sulcal tuberculomas compared with reference standard clinical composite criteria

Correlation of imaging findings with clinical outcomes

时间窗: 6 months to 18 months, average 9 months after starting treatment

Correlation of imaging findings in tubercular meningitis and spinal tubercular arachnoiditis with clinical outcomes after completion of therapy The outcome parameters of interest will be modified Rankin scale, visual acuity at 3 months and end of therapy.

次要结局

  • Factors determining outcomes in patients with spinal tubercular arachnoiditis(6 months to 18 months, average 9 months after starting treatment)
  • Clinical or imaging features of spinal tubercular arachnoiditis(Day 1 of diagnosis or imaging acquisition)
  • Treatment trends in patients with spinal tubercular arachnoiditis(6 months to 18 months, average 9 months after starting treatment)

研究者

发起方
All India Institute of Medical Sciences, New Delhi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Arunmozhimaran Elavarasi

Assistant Professor of Neurology

All India Institute of Medical Sciences, New Delhi

研究点 (1)

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