Intensified Treatment Regimens for TB Meningitis: PK, PD and Tolerability Study
Status:
Completed
Trial end date:
2012-06-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Universitas Padjadjaran
Collaborator:
Radboud University
Treatments:
Moxifloxacin Norgestimate, ethinyl estradiol drug combination