Rifampicin Explorative PK Study for Tuberculous Meningitis Comparing Oral and Intravenous Preparation
Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
Participant gender:
Summary
Tuberculous (TB) meningitis is the most severe manifestation of TB infection, leaving up to
50% of patients dead or neurologically disabled. Current treatment is similar to treatment of
lung TB, although penetration of some antibiotics into the brain is poor and the
immune-pathology of TB meningitis is very different from pulmonary TB. In a recent phase II
clinical trial from the investigators group, the first of its kind globally, intensified
antibiotic treatment, with moxifloxacin and high dose rifampicin, strongly reduced mortality
of TB meningitis.
The investigators aim to examine the effect of intensified antibiotic treatment on mortality
and morbidity of TB meningitis in a phase 3 clinical trial, preceded with an explorative
pharmacokinetic (PK) study to examine if higher oral doses rifampicin result in exposures
similar to the i.v. dose used in our phase 2 trial, since oral rifampicin could be
implemented much easier in low-resource settings.