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CTRI Number  CTRI/2021/04/032509 [Registered on: 01/04/2021] Trial Registered Prospectively
Last Modified On: 19/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To see how similar are the results of Truenat and CBNAAT (two tests used to diagnose Tuberculosis of the brain) in children. 
Scientific Title of Study   Evaluation of Truenat and CBNAAT for detection of Tubercular Meningitis in children and adolescents. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Stuti Sharma 
Designation  Post Graduate Student , MD Pediatrics 
Affiliation  Maulana Azad Medical College and Associated Lok Nayak Hospital 
Address  Department of Pediatrics, Maulana Azad Medical College and Associated Lok Nayak Hospital.

Central
DELHI
110002
India 
Phone  8988112042  
Fax    
Email  peds.stutisharma.2020@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anurag Agarwal 
Designation  Associate Professor 
Affiliation  Maulana Azad Medical College and Associated Lok Nayak Hospital 
Address  Department of Pediatrics, Maulana Azad Medical College and Associated Lok Nayak Hospital.

Central
DELHI
110002
India 
Phone  9810409625  
Fax    
Email  doctoranuragagarwal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Stuti Sharma 
Designation  Post Graduate Student , MD Pediatrics 
Affiliation  Maulana Azad Medical College and Associated Lok Nayak Hospital 
Address  Department of Pediatrics, Maulana Azad Medical College and Associated Lok Nayak Hospital.

Central
DELHI
110002
India 
Phone  8988112042  
Fax    
Email  peds.stutisharma.2020@gmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  Department of Pediatrics 
Address  Department of Pediatrics Maulana Azad Medical college and Associated Lok Nayak Hospital 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Stuti Sharma  Maulana Azad Medical college and Associated Lok Nayak Hospital  Department of Pediatrics
Central
DELHI 		 8988112042

peds.stutisharma.2020@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee. Maulana Azad Medical college and Associated Lok Nayak Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A170||Tuberculous meningitis, (2) ICD-10 Condition: A170||Tuberculous meningitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  18.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  None 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Cohens kappa coefficient to find out the degree of reliability between MTB detection by Truenat and CBNAAT in CSF samples.  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Difference in proportions of positivity status of CBNAAT and Truenat with respect to severity of disease.

 		 1 year

 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/04/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response (Others) -  nil

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identiļ¬ed for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  email - peds.stutisharma.2020@gmail.com

  6. For how long will this data be available start date provided 14-06-2022 and end date provided 01-01-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
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. 
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