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Paradoxical reaction in tuberculous meningitis effect of standard vs extended adjunctive corticosteroid treatment, a double blind placebo randomized controlled trial.

Paradoxical reaction in tuberculous meningitis effect of standard vs extended adjunctive corticosteroid treatment, a double blind placebo randomized controlled trial. - PRECISE-TBM

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/091592
Enrollment
104
Registered
2025-07-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G01- Meningitis in bacterial diseases classified elsewhere

Interventions

Intervention1: 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 i

Sponsors

Professor Jayantee Kalita
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Paradoxical reaction at 6weeks and 3months between standard and extended corticosteroid groupTimepoint: Paradoxical reaction at 6weeks and 3months between standard and extended corticosteroid group

Secondary

MeasureTime frame
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. Timepoint: 6 weeks and 3months and 6 months

Countries

India

Contacts

Public ContactProfessor Jayantee Kalita

Sanjay gandhi post graduate institute of medical sciences

jayanteek@yahoo.com05222494177

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026