Pharmacokinetics Clinical Trial
Official title:
Comparison of Intensive Treatment Regimens and Standard Treatment Regimen for Tuberculous Meningitis: Pharmacokinetics, Pharmacodynamics and Tolerability Study
Tuberculous meningitis (TBM) is the most lethal form of tuberculosis infection, and is
diagnosed in approximately 5-10% of TB patients. The incidence of TBM has increased
considerably during the last decade, partly due to the HIV epidemic. Without treatment,
virtually all patients with TB meningitis will die. With the current treatment regimens, TBM
is fatal in approximately 30-50% of cases, and responsible for severe disability in a
similar proportion of survivors.
Worldwide, Indonesia the third highest case load of tuberculosis with an estimated 500,000
new patients / year. Representative data are lacking, but it is clear that TBM is a growing
problem. For instance, in Hasan Sadikin Hospital, the top-referral hospital for West Java
Province (population 40 million), Indonesia, 40-50 cases of TBM were treated yearly in the
late 90's compared to approximately 100 in recent years.
There is very little evidence for the current treatment regimen for TBM, which dates back to
the late 60's. Therefore, there is an urgent need to evaluate intensified treatment of TBM
in randomized trials. We hypothesize that higher dose rifampicin, moxifloxacin (possibly
also at high dose), or both will improve outcome of TBM. To determine the experimental
regimen(s) which should be compared with current regimen in phase 3 trials, we want to
evaluate pharmacokinetic aspects and toxicity of candidate regimens in a phase 2 clinical
trial in 60 patients with TBM in Indonesia.
n/a
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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