Tuberculous meningitis Infections and Infestations Tuberculous meningitis
Conditions
Interventions
Adults entering the study will be randomised to one of four treatment arms:
1. Conventional four drug Anti-Tuberculosis Chemotherapy (ATC) (comprising of isoniazid, rifampicin, pyrazinamide and etham
Sponsors
University of Oxford (UK)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged over 14 years 2. Clinical diagnosis of TBM
Exclusion criteria
Exclusion criteria: 1. Patients who are less than 15 years old 2. Patients who are pregnant or breast feeding 3. Patients in whom the physician believes fluoroquinolones are contraindicated e.g. previous adverse reaction 4. The consent of either the patient or their relatives is not obtained
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Clinical methods: the following will be used as markers of clinical response: a. fever clearance, coma clearance, date of discharge, death at two months, disability or death at nine months b. CSF pressure, lactate, white cell count, protein and glucose 2. Microbiological methods: we will attempt to demonstrate microbiological activity by two methods: a. time to CSF sterility - serial lumbar punctures will allow us to assess the time taken to kill TBM in the CSF. 60% of adults with TBM isolated from the CSF before treatment have a sterile CSF after 48 hours of treatment, and 5% (often with resistant organisms) have TBM cultured from the CSF after 30 days of treatment (unpublished data from HTD). We aim to compare time to CSF sterility in the four treatment arms b. time to negative CSF amplified TBM direct test (Mycobacterium Tuberculosis Direct [MTD] test: Gen-probe, California). Using the same principles described above, we will compare time to negative MTD in the four treatment arms | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
Viet Nam
Outcome results
None listed