To observe if administration of drug namely linezolid along with standard four drug regimen in intensive(initial) phase of Tubercular meningitis will help reduce death and disability among patients when compared to standard four drugAntitubercular drug therapy alone.
Phase 2
- Conditions
- Health Condition 1: A170- Tuberculous meningitis
- Registration Number
- CTRI/2019/06/019501
- Lead Sponsor
- Aiims
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Age 18 years old or older
2.Willing to participate in the study by signing informed consent
3.Clinically diagnosed as TB meningitis by standard criteria using clinical, CSF and radiological findings
Exclusion Criteria
1.Failure to perform lumbar puncture
2.HIV positivity
3.Disseminated tuberculosis
4.Proven MDR, XDR TB
5.Confirmed meningitis other than TB
6.On tubercular drug for more than 15 days
7.Current treatment with: MAO inhibitors, direct and indirect acting sympathomimetic drugs
8.Pregnant or lactating female
9.Hepatic insufficiency (ALT >5x upper normal limit)
10.Kidney dysfunction (eGFR <50ml/min)
11.Known hypersensitivity to rifampicin and/or linezolid
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Efficacy Outcome <br/ ><br> <br/ ><br>Reduction in mortality at day 30 and 3 months for current study. <br/ ><br> <br/ ><br>Primary Safety Outcome <br/ ><br> <br/ ><br>Serious adverse event assessed during the period of intensive treatment including but not restricted to the following: day 7, 14, 30, including gastrointenstinal, hematological, neurological and visual dysfunction. <br/ ><br>Timepoint: At Admission,Day 14, One Month And 3 Months.
- Secondary Outcome Measures
Name Time Method 1. Early neurological improvement. Change in GCS at day 14 and 30 . <br/ ><br> <br/ ><br>2. Reduction in complications: hydrocephalus, stroke/ cerebral infarction at day 30 on CT scan and visual dysfunction. <br/ ><br> <br/ ><br>3. mRS outcome at 3 months and on routine follow up in the OPD at 6, 12 months. <br/ ><br> <br/ ><br>Timepoint: At Admission,Day 14, One Month And 3 Months