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

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.