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CTRI Number  CTRI/2019/05/019222 [Registered on: 20/05/2019] Trial Registered Prospectively
Last Modified On: 18/11/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A Comparative study of different treatment regimes for brain tuberculosis 
Scientific Title of Study   A Comparative study comparing intensified treatment with Moxifloxacin/Pyrazinamide versus standard Anti-tubercular therapy for CNS Tuberculoma  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nalini Atchayaram 
Designation  Professor 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Neurology National Institute of Mental Health and Neurosciences Bangalore-29
Hosur Road, Bangalore-560029
Bangalore
KARNATAKA
560029
India 
Phone  9632505634  
Fax    
Email  atchayaramnalini@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Nalini Atchayaram 
Designation  Professor 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Neurology National Institute of Mental Health and Neurosciences Bangalore-29
Hosur Road, Bangalore-560029
Bangalore
KARNATAKA
560029
India 
Phone  9632505634  
Fax    
Email  atchayaramnalini@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Nalini Atchayaram 
Designation  Professor 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Neurology National Institute of Mental Health and Neurosciences Bangalore-29
Hosur Road, Bangalore-560029
Bangalore
KARNATAKA
560029
India 
Phone  9632505634  
Fax    
Email  atchayaramnalini@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Science and Technology Technology Bhavan, New Mehrauli Road,, New Delhi-110 016.  
 
Primary Sponsor  
Name  Department of Science and Technology 
Address  Technology Bhavan, New Mehrauli Road,, New Delhi-110 016. 
Type of Sponsor  Government funding agency 
 
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 Nalini A  NIMHANS  Department of Neurology, Neurosciences Faculty Center,1st floor-Neurology Wing A, Hosur Road Bangaluru-560029
Bangalore
KARNATAKA 		 9632505634

atchayaramnalini@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMHANS ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A171||Meningeal tuberculoma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  4-drug ATT  Group A- 4-drug ATT: INH, Rifampicin, Pyrazinamide, Ethambutol in the 1st 2 months of Intensive phase followed by 2 drugs (INH, Rifampicin) in the maintenance phase.Group C- 4-drug ATT: INH, Rifampicin, Pyrazinamide, Ethambutol in the 1st 2 months of Intensive phase followed by 3 drugs (INH, Rifampicin, Pyrazinamide) in the maintenance phase. 
Intervention  Moxifloxacin/Pyrazinamide VS standard antitubercular therapy   Group B- 5-drug ATT: INH, Rifampicin, Pyrazinamide, Ethambutol and Moxifloxacin in the 1st 2 months of Intensive phase followed by 3 drugs (INH, Rifampicin and Moxifloxacin in the maintenance phase.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Clinically and radiologically suspected cases of CNS tuberculoma 
 
ExclusionCriteria 
Details  <18yrs, pregnant, HIV positive,refusal to participate in the study 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in size/disappearance of Tuberculoma  3 months, 6 months, 12 months, 18 months 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in clinical parameters,symptoms and signs like headache,focal deficits and reduction in disability scores.
 		 3 months, 6 months, 12 months, 18 months 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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   Phase 1 
Date of First Enrollment (India)   27/05/2019 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

  1. This is a prospective randomised clinical study comprising of 25 patients in each arm using random table method:Group A- 4-drug ATT: INH, Rifampicin, Pyrazinamide, Ethambutol in the 1st 2 months of Intensive phase followed by 2 drugs (INH, Rifampicin) in the maintenance phase. Group B- 5-drug ATT: INH, Rifampicin, Pyrazinamide, Ethambutol and Moxifloxacin in the 1st 2 months of Intensive phase followed by 3 drugs (INH, Rifampicin and Moxifloxacin in the maintenance phase. Group C- 4-drug ATT: INH, Rifampicin, Pyrazinamide, Ethambutol in the 1st 2 months of Intensive phase followed by 3 drugs (INH, Rifampicin, Pyrazinamide) in the maintenance phase. The aims and objectives are to compare the effect of the 3 regimens in the resolution of  Brain Tuberculomas, to check if resolution of Tuberculomas begins faster with 5 drug regime or intensification of the 1st line drugs, to check the time taken for complete resolution of Tuberculomas in the three groups, to assess the post resolution residual damage to the brain between the three groups and to correlate the clinical features, cytokines level and neuroimaging. The recruitment phase of this study is for 18 months followed by 18 months of follow up with visits every 3 months with clinical exams and serial MRI imaging at each visit.

 
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