Health Condition 1: A179- Tuberculosis of nervous system, unspecified
Conditions
Interventions
Intervention1: Capsule Thalidomide: Patients allocated to intervention group will receive capsule thalidomide 50mg twice daily (patient’s weight 50kg) or thrice daily (weight = 50kg) for 3 to 6 months
Sponsors
PGIMER Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: Possible, probable, or definite TBM as diagnosed by Marais et al criteria. Patients already on standard ATT and steroid protocol for CNS TB who develop complications in the form of paradoxical worsening like opto-chiasmatic syndrome, spinal arachnoiditis, increase in tuberculomas, exudates or clinical worsening etc. Patients willing to be followed up for at least 6 months for assessment.
Exclusion criteria
Exclusion criteria: 1. Patients who are either HIV positive or immunocompromised due to some other disease. 2. Patients are on immunosuppressive drugs. 3. Patients who cannot undergo lumbar puncture or MRI examination. 4. Pregnant patients. 5. CSF gram stain or/and culture showing microorganisms other than acid fast bacilli.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome – Mortality at 6 months of intervention. Secondary outcome – •Clinical improvement oFunctional status – mRS scale. oVision – Grading of Visual Acuity •Radiological improvement oExudates – Present or absent. oTuberculomas – Number oInfarct – Present or absent. oHydrocephalus – Present or absent. •Presence of neurological deficit •Side effects of thalidomide Timepoint: Primary outcome – Mortality at 6 months of intervention. Secondary outcome – •Clinical improvement oFunctional status – mRS scale. oVision – Grading of Visual Acuity •Radiological improvement oExudates – Present or absent. oTuberculomas – Number oInfarct – Present or absent. oHydrocephalus – Present or absent. •Presence of neurological deficit •Side effects of thalidomide | — |
Secondary
| Measure | Time frame |
|---|---|
| • Clinical improvement o Functional status – mRS scale. o Vision – Grading of Visual Acuity (Wall et al) (36) Grading Visual Acuity Mild vision loss 6/9 – 6/12 Moderate Vision loss 6/18 – 6/60 Severe Vision loss 6/60 • Radiological improvement o Exudates – Present or absent. o Tuberculomas – Number o Infarct – Present or absent. o Hydrocephalus – Present or absent. • Presence of neurological deficit • Side effects of thalidomide Timepoint: 1,2,3,4,5,6 months | — |
Countries
India
Contacts
Public ContactSiddharth Chand
PGIMER, Chandigarh
Outcome results
None listed