| 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
|
|
|
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
|
|
|
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.
|