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CTRI Number  CTRI/2024/07/070282 [Registered on: 09/07/2024] Trial Registered Prospectively
Last Modified On: 08/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Levofloxacin in treatment of tuberculosis infection of brain in children 
Scientific Title of Study   Evaluation of efficacy of add on oral levofloxacin in children with tubercular meningitis aged 6 months-18 years: A randomized controlled trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Achanya P  
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  6th floor, Department of Pediatrics All India Institute of Medical Sciences Virbhadra Road Rishikesh Uttarakhand

Dehradun
UTTARANCHAL
249203
India 
Phone  7087382348  
Fax    
Email  achu8101p@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Indar Kumar Sharawat 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  6th floor, Department of Pediatrics All India Institute of Medical Sciences Virbhadra Road Rishikesh Uttarakhand

Dehradun
UTTARANCHAL
249203
India 
Phone  9560182301  
Fax    
Email  sherawatdrindar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Indar Kumar Sharawat 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  6th floor, Department of Pediatrics All India Institute of Medical Sciences Virbhadra Road Rishikesh Uttarakhand

Dehradun
UTTARANCHAL
249203
India 
Phone  9560182301  
Fax    
Email  sherawatdrindar@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Rishikesh Dehradun UTTARANCHAL 249203 India  
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, Rishikesh 
Address  All India Institute of Medical Sciences Virbhadra Road Rishikesh Dehradun district Uttarakhand Pin code: 249203 India  
Type of Sponsor  Research institution and hospital 
 
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 Achanya P  All India Institute of Medical Sciences, Rishikesh  6th floor, Department of Pediatrics All India Institute of Medical Sciences Virbhadra Road Rishikesh Uttarakhand
Dehradun
UTTARANCHAL 		 7087382348

achu8101p@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, All India Institute of Medical Sciences, Rishikesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A170||Tuberculous meningitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Levofloxacin add on to the intensive phase of standard anti tubercular therapy  Add on oral levofloxacin in a dose of 10 mg/kg/day (once daily in children older than 5 years and in two divided doses for children ≤5 years of age, maximum dose 500 mg per day) will be administered to all participants in intervention group daily for 8 weeks in addition to standard anti tubercular therapy in the intensive phase 
Comparator Agent  Standard Anti tubercular therapy  Standard Anti tubercular therapy would be provided  
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Diagnosed cases of tubercular meningitis presenting to Department of Pediatrics, All India Institute Medical Sciences, Rishikesh with a diagnosis of TB meningitis as per Marais’ criteria and parents willing to comply with the study protocol and follow up  
 
ExclusionCriteria 
Details  Pre-existing major chronic systemic illness including cardiovascular (arrhythmia, prolonged QTc interval or history of any arrhythmia), respiratory (chronic lung disease), gastrointestinal system (chronic liver disease) or chronic renal disease  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Functional Status Scale   12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Functional status scale  12 weeks 
Pediatric Cerebral Performance Category  12 weeks 
Survival  12 weeks 
Duration of hospitalisation  At diagnosis 
Number of patients with paradoxical reaction   within 12 weeks 
Social quotient by Vineland Social Maturity Scale  12 weeks 
Childhood Behavioural Checklist internalizing, externalizing and total score  12 weeks 
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
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 2 
Date of First Enrollment (India)   19/07/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The RCT will evaluate the efficacy of add on oral levofloxacin during first 8 weeks of intensive phase of anti-tubercular therapy in improving the functional outcome at 12 weeks in pediatric patients with  CNS tuberculosis aged 6 months- 18 years, as compared to standard care alone 
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