Health Condition 1: A179- Tuberculosis of nervous system, unspecified
Conditions
Interventions
Intervention1: Thalidomide: Thalidomide will be given orally in a dose of 3mg/kg body weight per day for 3 months and then gradually tapered off over 3 months
Control Intervention1: Infliximab: Inflix
Sponsors
ICMR New Delhi INDIA
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18 years or more 2. Confirmed cases of CNS TB with Paradoxical response based on clinical, biochemical (CSF) and radiological imaging. 3. Willingness to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Patients less than 18 years 2. Patients having MDR TB. 3. Patients in whom the symptoms were better explained by some other cause as per abnormalities in the investigations performed 4. Patients not willing to give written informed consent or Assent 5. Other similar diseases mimicking TBM like fungal infections, etc. 6. Pregnancy 7. Patients with HIV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the clinical outcome in patients of CNS TB with paradoxical responseTimepoint: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To study the radiological outcome on follow up along with clinical parametersTimepoint: At end of 3 months, 6 months and completion of therapy;2. To study cytokine levels in CSF and Blood at time of recruitment and Changes in blood on follow up after 3 monthsTimepoint: At Baseline and at 3 months | — |
Countries
India
Contacts
Public ContactManish Modi
PGIMER
Outcome results
None listed