Intensified treatment for tuberculous meningitis to reduce mortality

Phase 4

Completed

• Conditions: Tuberculous meningitis; Infections and Infestations; Tuberculosis of nervous system

• Registration Number: ISRCTN61649292
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21288325 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21288326 2016 results in http://www.ncbi.nlm.nih.gov/pubmed/26760084 2020 results in https://pubmed.ncbi.nlm.nih.gov/31956998/ (added 28/10/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-06
• Study Completion: 2015-03-15
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 817

Inclusion Criteria

Greater or equal to 15 years of age (either sex) with a clinical diagnosis of tuberculous meningitis

Exclusion Criteria

1. Positive cerebrospinal fluid (CSF) Gram or India Ink stain
2. Known or suspected pregnancy
3. Known hypersensitivity/intolerance to fluoroquinolones or rifampicin
4. Estimated glomerular filtration rate (GFR) less than 40 ml/min
5. Laboratory contraindications to antituberculous therapy:
5.1. Bilirubin greater than 2.5 x upper limit of normal (ULN)
5.2. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 5 x ULN
6. Lack of consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival during a follow-up period of 9 months