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To study if 9 of treatment is non-inferior to 12 months or 18 months of treatment for brain fever due to tuberculosis (Tuberculous meningitis (TBM))

Determination of efficacy of 9 months, 12 months and 18 months of Anti-Tubercular treatment (ATT) for Tuberculous Meningitis (TBM): A randomized controlled, non-inferiority trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/02/011658
Enrollment
232
Registered
2018-02-02
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Health Condition 1: null- Tuberculous meningitis Health Condition 2: A170- Tuberculous meningitis

Interventions

Intervention1: 12 months ATT(Group B): Group B Intensive phase (2-3 months): Rifampicin (R) (10 mg/kg/day) oral, usual 600 mg Isoniazid (H)(5 mg/kg/day) oral, usual 300 mg Pyrazinamide (Z) (20-25 mg/

Sponsors

Department of Health Research DHR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All of the following: 1. All patients with suspected tuberculous meningitis (TBM) according the criteria by Marais et al. (Marais et al., 2010b) 2. All stages of TBM will be included 3. Patients who consent for the study and consent to undergo CSF analysis

Exclusion criteria

Exclusion criteria: Any of the following: 1. Patients who have associated cryptococcal meningitis 2. Patient who are HIV positive 3. Patients with hepatic or renal dysfunction, organ transplantation, malignancy, pregnancy, lactation 4. Patients with age 5. Patients who have proven drug resistant tuberculosis and have to be instituted longer treatment 6. Patients refusing to consent for the study

Design outcomes

Primary

MeasureTime frame
Combined relapse and mortalityTimepoint: At one year follow up after treatment

Secondary

MeasureTime frame
Other outcomes studied will be rate of relapse, mRS at at one year follow after after stopping treatmentTimepoint: 3, 6, 9, 12, 18 and 24 months

Countries

India

Contacts

Public ContactDeepti Vibha

All India Institute of Medical Sciences

deeptivibha@gmail.com01126593491

Outcome results

None listed

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