Health Condition 1: A170- Tuberculous meningitis
Conditions
Interventions
Intervention1: Prednisolone: Intervention-
First Group-
Prednisolone(0.75mg/kg/day, maximum 40mg/day) for 3 month, then taper in the next month
Frequency Once Daily
Route Oral
Total duration Three
Sponsors
Prakash Chandra Pandey
Eligibility
Inclusion criteria
Inclusion criteria: Patients with TBM The essential criteria include presence of meningitis symptoms comprising of fever, headache and vomiting for two week or more. The supportive criteria include (1) CSF cells 0.1 x 109/l or more with predominant lymphocytes, protein more than 1 gm/l, sterile bacterial and fungal culture; (2) CT or MRI scan evidences of exudates, infarctions, hydrocephalus and tuberculoma in isolation or in various combinations; (3) evidence of extra central nervous system tuberculosis and (4) response to anti-tubercular therapy. 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
Exclusion criteria
Exclusion criteria: 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, Age less than 15 years or more than 70 years, pregnancy, lactation, and those having life expectancy less than 6month due to other disease will be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in levels of cytokines TNF Alpha, IL Six , and IL TenTimepoint: Baseline,6 Weeks & 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Paradoxical Reaction Death within 3month Functional outcome at 3 & 6 months using modified Rankin Scale (mRS). Occurrence of drug induced hepatitis Occurrence of CSW Occurrence of visual loss Corticosteroid related side effects: hypertension, weight gain, hyperglycemia, infection, fracture etc Timepoint: 6 weeks & 3 months | — |
Countries
India
Contacts
Public ContactPrakash Chandra Pandey
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Outcome results
None listed