To study the benefit of Linezolid treatment in patients with Tubercular Meningitis.

ESCALATE 2: Linezolid As An Add-On Treatment In The Intensive Phase Of Tubercular Meningitis. A Randomised Controlled Trial - ESCALATE 2

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/099965

Enrollment

372

Registered

2025-12-30

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: - Health Condition 2: G00-G09- Inflammatory diseases of the central nervous system Health Condition 3: G01- Meningitis in bacterial diseases classified elsewhere

Interventions

Intervention1: Tablet Linezolid 600mg: Tablet Linezolid 600mg twice daily for one month and once daily for another one month. Total duration of two months during the intensive phase. Control Intervent

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age equal or more 18 years 2. Patients diagnosed with TBM using Marais et al. criteria for case definition of TBM 3. Within 15 days of starting ATT

Exclusion criteria

Exclusion criteria: 1. Patients with MDR, XDR tuberculosis 2. Meningitis other than TB 3. Failure to perform lumbar puncture 4. Patients with HIV. 5. ATT already started for more than 15 days 6. Already on linezolid therapy 7. Known allergy to linezolid 8. Thrombocytopenia ( platelets below 1 lac) 9. Bleeding disorder or active bleeding 10. Hepatic impairment. AST, ALT more than equal to three times elevation 11. Renal impairment. GFR more than 20 12. Visual impairment at baseline 13. Known history of peripheral neuropathy 14. Serious comorbid illness like malignancy which may limit life expectancy or follow up or drug interactions 15. Pregnancy or lactation 16. Concomitant use of other drugs that significantly interact with linezolid (e.g., MAO inhibitors) 17. Enrolled in another study 18. Denial of consent 19. Any other reason judged by the investigator.

Design outcomes

Primary

Measure	Time frame
Proportionate change in mortality between the two groups at one and three monthsTimepoint: one and three months	—

Secondary

Measure	Time frame
Proportionate difference in disability assessed on modified Rankin score (mRS) at 3 months with mRS less than or equal to 2 taken as a good outcome.Timepoint: 3 Months;Early neurological improvement assessed by change in Glasgow coma scale (GCS) on day 14 and day 30 of randomisation.Timepoint: 14 and day 30 of randomisation;Proportionate difference in disability assessed on modified Rankin score (mRS) at 3 months and 12 months (where possible) with mRS less than or equal to 2 taken as a good outcome.Timepoint: 3 months and 12 months	—

Measure

Time frame

Proportionate difference in disability assessed on modified Rankin score (mRS) at 3 months with mRS less than or equal to 2 taken as a good outcome.Timepoint: 3 Months;Early neurological improvement assessed by change in Glasgow coma scale (GCS) on day 14 and day 30 of randomisation.Timepoint: 14 and day 30 of randomisation;Proportionate difference in disability assessed on modified Rankin score (mRS) at 3 months and 12 months (where possible) with mRS less than or equal to 2 taken as a good outcome.Timepoint: 3 months and 12 months

—

Countries

India

Contacts

Public ContactDr Rohit Bhatia

All India Institute of Medical Sciences, New Delhi

rohitbhatia71@yahoo.com911126546625

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026