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

NCT05636254 | Unknown

• 1 other identifier: IECPG-36/27.01.2022
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

TBM

Outcome Measures

Primary Outcomes (2)

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

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

  Day 1 of diagnosis or imaging acquisition

• Correlation of imaging findings with clinical outcomes

  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.

  6 months to 18 months, average 9 months after starting treatment

Secondary Outcomes (3)

• Clinical or imaging features of spinal tubercular arachnoiditis

  Day 1 of diagnosis or imaging acquisition

• Factors determining outcomes in patients with spinal tubercular arachnoiditis

  6 months to 18 months, average 9 months after starting treatment

• Treatment trends in patients with spinal tubercular arachnoiditis

  6 months to 18 months, average 9 months after starting treatment

Study Arms (1)

Chronic Meningitis

* 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.

Diagnostic Test: MRI Brain and spine; Diagnostic Test: Reference standard diagnostic criteria

Interventions

MRI Brain and spine DIAGNOSTIC_TEST

* 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)

Chronic Meningitis

Reference standard diagnostic criteria DIAGNOSTIC_TEST

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

Also known as: Clinical composite criteria

Chronic Meningitis

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

▪ 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 less greater than age-specific normal value; especially \>1•0 g/L OR Glucose concentration 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

You may not qualify if:

• Not willing to provide consent

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

All India Institute of Medical Sciences, New Delhi

New Delhi, National Capital Territory of Delhi, 110029, India

RECRUITING

MeSH Terms

Conditions

Tuberculosis, Meningeal

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Tuberculosis, Central Nervous System; Tuberculosis, Extrapulmonary; Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Central Study Contacts

Arunmozhimaran Elavarasi, MD DM

CONTACT

+919013844274; arun_ela@yahoo.com

MV Padma Srivastava, MD DM

CONTACT

+919868398261; vasanthapadma123@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: December 5, 2022
• Study Start: January 27, 2022
• Primary Completion: January 1, 2024
• Study Completion: February 1, 2024
• Last Updated: December 5, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Within 3 months of request till five years after publication of results

Locations

IN (1)