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Clinical Trials/ISRCTN61649292
ISRCTN61649292
Completed
Phase 4

A randomised, double-blind, placebo-controlled trial to investigate the effect of intensified treatment with high dose rifampicin and levofloxacin for adult patients with tuberculous meningitis

niversity of Oxford (UK)0 sites817 target enrollmentOctober 6, 2009
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ConditionsTuberculosis of nervous systemTuberculous meningitisInfections and Infestations

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Tuberculosis of nervous system
Sponsor
niversity of Oxford (UK)
Enrollment
817
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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)

Registry
who.int
Start Date
October 6, 2009
End Date
March 15, 2015
Last Updated
5 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of Oxford (UK)

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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