Health Condition 1: null- patients with Tubercular meningitis.No history of HepatitisA,B,C,E,CLD,HIV,alcoholism,hepatotoxic drugs,CRF, hepatic failure and contra-indications to ATT,Pregnant and lactating women.
Conditions
Interventions
Intervention1: sequential Anti-tubercular arm: Patients in the intervention arm (sequential ATT arm) will receive ATT (in same dosage) sequentially as follows: H at dosage of 100 mg/day from day 1, ma
R at dosage of 150 mg/day from day 8, maximum dosage from day 11
and Z at dosage of 500 mg/day from day 15, maximum dosage from day 18. ethambutol will be added on day 1 at a dose of 800 mg,as it is not a hepato-toxic drug.
Control Intervention1: standard Anti-tube
Sponsors
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: All patients with fever and altered sensorium for 10 days or more. Diagnosed as Definite and probable tubercular meningitis diagnosed on the basis of clinical, CSF and radiological criteria. 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: Pregnant and lactating women. Serological evidence of Hepatitis A, B, C, E. Ultra-sonographic (USG) evidence of chronic liver disease (CLD) or gall bladder disease. HIV infection. long term alcoholism (defined as consumption of 148 g of alcohol per day for at least 1 year). concomitant consumption of other potentially hepatotoxic drugs (eg, methotrexate, phenytoin, valproate, and fluconazole. Failure to give written informed consent. Chronic renal failure Hepatic failure. Heart failure. Carcinomatous meningitis. Contra-indications to ATT, steroids or aspirin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence and predictors of DIH defined using the criteria stated above.Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Disability at discharge, 3 and 6 months based on modified Barthel index and m RS score. Mortality at 28 days, 3 months and 6 months. Residual deficits in terms of seizures, cognitive, cranial nerve and motor deficits at the end of 6 months. Timepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr U K Misra
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)
Outcome results
None listed