Health Condition 1: null- Stable as well as seriously ill patients will be enrolled
Conditions
Interventions
Intervention1: Dexamethasone
: 0.4 mg/kg(starting dose)
IV and oral routes for 8 weeks by directly switching IV to oral.
Control Intervention1: Dexamethasone: 0.4 mg/kg(starting dose)
IV and oral routes for 8 weeks by overlapping IV and oral.
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 12 years or above 2. Clinical evidence of Tubercular meningitis(TBM) in the form of fever and headache >14 days with/without vomiting or impaired consciousness along with one sign of meningeal irritation. 3. Along with the clinical criteria any one of the following: a. CSF evidence of lymphocytic pleocytosis( >20 TLC with >60% lymphocytes) and low sugar( 100 mg%) b. Radiological involvement- 2 or more of the following- Basal exudates,hydrocephalous, infarcts or gyral enhancement. c. Extraneural TB- active tuberculosis involving lung, GI Tract, lymph nodes, skeletal and skin 3. Signed and informed consent.
Exclusion criteria
Exclusion criteria: a. Alternative diagnosis (non TB infection, malignancy on basis of CSF or imaging) b. Contraindications to steroids or anti-tubercular treatment(Liver disease, history of GI bleed, duodenal ulcer or malignant hypertension or pregnant women)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resolution of clinical symptoms(Headache, fever, loss of consciousness) at the end of one month of randomization.Timepoint: End of 1 month post randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mortality 2. Modified Rankin ScoreTimepoint: at end of 6 months post randomization | — |
Countries
India
Contacts
Public ContactDr Alvee Saluja
All India Institute Of Medical Sciences
Outcome results
None listed