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Diagnostic Accuracy of Imaging Findings in TBM/Spinal Tubercular Arachnoiditis and Correlation With Outcomes

NCT05636254 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2022-12-05

No results posted yet for this study

Summary

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.

Conditions

  • Tuberculous Meningitis
  • Tuberculous Arachnoiditis

Interventions

DIAGNOSTIC_TEST

MRI Brain and spine

* MRI Brain * Ax T2 TSE * 3D Sag T1 * Ax DWI * 3D Sag Flair * Ax SWI * Post-gad 3D Sag T1 * 3D TOF Circle-of-Willis * MRI Spine * Sag T2 whole spine (2 stations) * Post-gad Sag T1 whole spine (2 stations)

DIAGNOSTIC_TEST

Reference standard diagnostic criteria

Diagnostic criteria-TBM * Microbiologic evidence of TB in CSF * Microbiologic evidence of TB from pulmonary or extrapulmonary sites * Reasonable clinical certainty OR allied investigations such as CXR/CECT chest/abdomen/PET CT as per clinical indication suggestive of tuberculosis * Other relevant investigations like CSF analysis not suggestive of alternative diagnosis such as neurocysticercosis/cryptococcal/other fungal infections/other causes of chronic meningitis such as brucella/ nocardia/ syphilis/recurrent viral meningitis/ carcinomatous/ lymphomatous meningitis or non infective causes such as sarcoidoisis/sub-arachnoid hemorrhage etc. * Reasonable clinical certainty OR allied investigations such as CXR/CECT chest/abdomen/PET CT as per clinical indication ruling out competing diagnoses * Patients who develop features or test results suggestive of alternative diagnosis with will be considered to be not due to tubercular meningitis

Sponsors & Collaborators

  • All India Institute of Medical Sciences

    lead OTHER

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-27
Primary Completion
2024-01-31
Completion
2024-02-29

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05636254 on ClinicalTrials.gov