A randomised comparison of ciprofloxacin, levofloxacin and gatifloxacin for the treatment of adults with tuberculous meningitis

Completed

Conditions: Tuberculous meningitis
Infections and Infestations

Registration Number: ISRCTN07062956

Lead Sponsor: niversity of Oxford (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Aged over 14 years
2. Clinical diagnosis of TBM

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Clinical methods: the following will be used as markers of clinical response: <br>a. fever clearance, coma clearance, date of discharge, death at two months, disability or death at nine months<br>b. CSF pressure, lactate, white cell count, protein and glucose<br>2. Microbiological methods: we will attempt to demonstrate microbiological activity by two methods:<br>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hours of treatment, and 5% (often with resistant organisms) have TBM cultured from the CSF after 30 days of treatment (unpublished data from HTD).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<br>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 Outcome Measures