Health Condition 1: A170- Tuberculous meningitis
Conditions
Interventions
Intervention1: Linezolid Plus Standard Four Drug Att In Intensive Phase: Addition Of Linezolid In Dosage of 600 mg bd Orally for 28 Days To Standard Four Drug Att. Intensive Phase Of Tubercular Men
Sponsors
Aiims
Eligibility
Inclusion criteria
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
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 11. Known hypersensitivity to rifampicin and/or linezolid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy Outcome Reduction in mortality at day 30 and 3 months for current study. Primary Safety Outcome 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. Timepoint: At Admission,Day 14, One Month And 3 Months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Early neurological improvement. Change in GCS at day 14 and 30 . 2. Reduction in complications: hydrocephalus, stroke/ cerebral infarction at day 30 on CT scan and visual dysfunction. 3. mRS outcome at 3 months and on routine follow up in the OPD at 6, 12 months. Timepoint: At Admission,Day 14, One Month And 3 Months | — |
Countries
India
Contacts
Public ContactDr Rohit Bhatia
AIIMS NEW DELHI
Outcome results
None listed