side-effect profile and outcome of patients receiving four drug ATT sequentially compared to standard four drug ATTâ?? in patients with tubercular meningitis
- Conditions
- 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.
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence and predictors of DIH defined using the criteria stated above.Timepoint: 6 months
- Secondary Outcome Measures
Name Time Method Disability at discharge, 3 and 6 months based on modified Barthel index and m RS score. <br/ ><br>Mortality at 28 days, 3 months and 6 months. <br/ ><br>Residual deficits in terms of seizures, cognitive, cranial nerve and motor deficits at the end of 6 months. <br/ ><br>Timepoint: 6 months