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Clinical Trials/CTRI/2021/04/032509
CTRI/2021/04/032509Not yet recruitingNot Applicable

Evaluation of Truenat and CBNAAT for detection of Tubercular Meningitis in children and adolescents.

Department of Pediatrics1 site in 1 country70 target enrollmentStarted: October 4, 2021Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
70
Locations
1
Primary Endpoint
Cohens kappa coefficient to find out the degree of reliability between MTB detection by Truenat and CBNAAT in CSF samples.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study is being conducted to evaluate the role of Truenat vs CBNAAT for the diagnosis of Tubercular Meningitis in children and adolescents.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
0.00 Day(s) to 18.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Suspected case of Tubercular Meningitis13 as evidenced by: Fever >5days, weight loss, anorexia along with neurological signs and symptoms (headache, vomiting, irritability, lethargy, seizures, confusion, coma, neck stiffness, cranial nerve palsy, hemiparesis) and CSF showing presence of 10-500 WBC/mm3, lymphocytes >50% and CSF/Plasma glucose <50% and WBC in blood <15x109/lt And/or imaging with evidence of basal meningeal enhancement, hydrocephalous or cerebral infarct or tuberculoma.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Cohens kappa coefficient to find out the degree of reliability between MTB detection by Truenat and CBNAAT in CSF samples.

Time Frame: 1 year

Secondary Outcomes

  • Difference in proportions of positivity status of CBNAAT and Truenat with respect to severity of disease.

Investigators

Sponsor Class
Government medical college

Study Sites (1)

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