Diagnostic Accuracy of Imaging Findings in Tubercular Meningitis/Spinal Tubercular Arachnoiditis and Correlation With Outcomes in Patients With Tubercular Meningitis, Spinal Tubercular Arachnoiditis
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
- 否
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
Arunmozhimaran Elavarasi
Assistant Professor of Neurology
All India Institute of Medical Sciences, New Delhi
