FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/091592 [Registered on: 24/07/2025] Trial Registered Prospectively
Last Modified On: 23/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Paradoxical reaction in tuberculous meningitis effect of standard vs extended adjunctive corticosteroid treatment, a double blind placebo randomized controlled trial. 
Scientific Title of Study   Paradoxical reaction in tuberculous meningitis effect of standard vs extended adjunctive corticosteroid treatment, a double blind placebo randomized controlled trial. 
Trial Acronym  PRECISE-TBM 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Professor Jayantee Kalita 
Designation  Professor and head 
Affiliation  Sanjay gandhi post graduate institute of medical sciences 
Address  Department of neurology,sanjay gandhi post graduate institute of medical sciences

Lucknow
UTTAR PRADESH
226014
India 
Phone  05222494177  
Fax    
Email  jayanteek@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Professor Jayantee Kalita 
Designation  Professor and Head 
Affiliation  Sanjay gandhi post graduate institute of medical sciences 
Address  Department of neurology,sanjay gandhi post graduate institute of medical sciences

Lucknow
UTTAR PRADESH
226014
India 
Phone  05222494177  
Fax    
Email  jayanteek@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Professor Jayantee Kalita 
Designation  Professor and Head 
Affiliation  Sanjay gandhi post graduate institute of medical sciences 
Address  Department of neurology,sanjay gandhi post graduate institute of medical sciences

Lucknow
UTTAR PRADESH
226014
India 
Phone  05222494177  
Fax    
Email  jayanteek@yahoo.com  
 
Source of Monetary or Material Support  
Department of Neurology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Raebareli Road, Lucknow, Uttar Pradesh, India-226014 
 
Primary Sponsor  
Name  Professor Jayantee Kalita 
Address  Department of neurology, sanjay gandhi post graduate institute of medical sciences, Raebareli Road Lucknow,Uttar Pradesh 
Type of Sponsor  Other [Self] 
 
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 
Professor Jayantee Kalita  Sanjay Gandhi Post Graduate Institute of Medical Sciences   Department of neurology, sanjay gandhi post graduate institute of medical sciences, Raebareli Road Lucknow,Uttar Pradesh
Lucknow
UTTAR PRADESH 
05222494177

jayanteek@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sanjay Gandhi Post Graduate Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G01||Meningitis in bacterial diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Extended Prednisolone therapy  Extended group will receive weight based prednisolone for 2 months then tapered off in 3 rd month.Prednisolone will be taperedby 10mg every week and 5mg in last week and stopped.The number of tablets between two group will be maintained by giving identical saccharine tablets. 
Comparator Agent  Standard Prednisolone therapy  Standard prednisolone regimen (0.75mg/kg),maximum 40mg/day for 1 month ,then tapered the next month .Prednisolone will be tapered by 10mg every week and 5mg in last week and stopped.The number of tablets between two group will be maintained by giving identical saccharine tablets. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients with diagnosed TBM on the following criteria.
Presence of essential and 3 of 4 supportive criteria will be considered highly probable and 2 supportive criteria as probable TBM. Presence of AFB in CSF smear or culture, positive PCR for M. tuberculosis in CSF will be considered definitive evidence of TBM
2-Age 15years to 70 years
3-Gender-Both male and female
 
 
ExclusionCriteria 
Details  The patients with malaria, septic, fungal and carcinomatous meningitis, HIV, resistant TB, head injury, stroke, tumors, malignancy, chronic renal failure, hepatic failure, heart failure, chronic obstructive pulmonary disease, asthma children less than 15 years and elderly more than 70 years ,pregnancy, lactation, and those having life expectancy less than 6month due to other disease will be excluded. The antitubercular drug induced hepatitis however will be included. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Paradoxical reaction at 6weeks and 3months between standard and extended corticosteroid group  Paradoxical reaction at 6weeks and 3months between standard and extended corticosteroid group 
 
Secondary Outcome  
Outcome  TimePoints 
1.Death within 3month

2.Functional outcome at 3 and 6 months using modified Rankin Scale (mRS).

3.Occurrence of drug induced hepatitis

4. Occurrence of CSW

5. Occurrence of visual loss

6. Corticosteroid related side effects: hypertension, weight gain, hyperglycemia, infection, fracture.
 
6 weeks and 3months and 6 months 
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
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 4 
Date of First Enrollment (India)   11/08/2025 
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  

Tuberculous meningitis (TBM) is the most severe manifestation of tuberculosis, with high mortality and neurological morbidity. A significant proportion (40–60%) of TBM patients experience paradoxical reactions (PR) despite appropriate anti-tubercular treatment (ATT), characterized by new or worsening clinical and radiological findings. Adjunctive corticosteroids are known to reduce mortality, typically administered for one month. However, their role in mitigating PR remains unclear. This double-blind, placebo-controlled randomized trial aims to compare the efficacy of standard (1-month) versus extended (2-month) adjunctive corticosteroid therapy in reducing PR among TBM patients.

Patients aged 15–70 years meeting diagnostic criteria for TBM will be randomized to receive either standard or extended oral prednisolone (0.75 mg/kg/day, maximum 40 mg/day), with both groups undergoing a gradual tapering protocol. All patients will receive  standard ATT and aspirin. Exclusion criteria includes HIV, malignancy, organ failure, and alternative meningitis etiologies. Clinical evaluations, neuroimaging, and CSF analysis will beperformed at baseline, 6 weeks, and 3 months. The primary outcome will be the incidence of PR at 6 weeks and 3 months. Secondary outcomes included mortality, functional status (modified Rankin Scale), drug-induced hepatitis, cerebral salt wasting, visual loss, and steroid-related complications.


 
Close