Health Condition 1: null- Patients with Tuberculous Meningitis.
Conditions
Interventions
Intervention1: Levofloxacin: Dose 10 mg/kg/day (Max 500 mg/day) once daily orally for 1 year
Control Intervention1: Rifampicin: 10 mg/kg/day (Max 450 mg/day) once daily orally for 1 year
Sponsors
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: Patients with TBM diagnosed on the basis of clinical, CSF and radiological criteria will be included. The essential criteria is the presence of meningitic symptoms comprising of fever, headache and vomiting for 2 weeks or more in whom malaria, septic and fungal meningitis were excluded. The supportive criteria include: 1) CSF cells 0.2x 109/L or more with predominant lymphocyte, protein >1g/L, sterile bacterial (other than AFB) and fungal culture and negative cryptococcal antigen. 2) CT or MRI evidence of infarction, exudates, tuberculoma or hydrocephalus. 3) Evidence of extra CNS tuberculosis. Presence of the essential criteria and any of the supportive criteria is considered TBM. Presence of AFB in CSF or culture (BACTEC) and positive AFB PCR or IgM antibodies in CSF are considered diagnostic of TBM
Exclusion criteria
Exclusion criteria: Patients who have received >1 month ATT from outside, children, pregnant and lactating women, patients with history of liver and kidney failure and malignancy will be excluded. Patients with epilepsy will be excluded. Patients with seizures as a manifestation of meningitis will also be excluded. Patients with malaria, septic, fungal and carcinomatous meningitides will also be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality at 6 months.Timepoint: 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Functional outcome as per Barthel Index score. 2. Safety and tolerability of drug.Timepoint: 6 months. | — |
Countries
India
Contacts
Public ContactDr Sreeram Prasad A V
Sanjay Gandhi Postgraduate Institute.
Outcome results
None listed