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Innovative PK/PD approaches to optimize tuberculosis meningitis treatment in children: Use of modeling to design confirmatory pediatric clinical trial

Innovative PK/PD approaches to optimize tuberculosis meningitis treatment in children: Use of modeling to design confirmatory pediatric clinical trial
Rovina Ruslami, MD.,Ph.D
Universitas Padjadjaran, Presented At 6th International Workshop on Clinical Pharmacology of Tuberculosis Drugs Denver, CO, USA 9 September 2013
Bahasa Inggris
Universitas Padjadjaran, Presented At 6th International Workshop on Clinical Pharmacology of Tuberculosis Drugs Denver, CO, USA 9 September 2013

Tuberculosis Meningitis (TBM) disproportionally affects young children. The mortality and morbidity of TBM is high1, with only about 20% of children functionally normal after suffered from TBM.2 For all forms of drug sensitive-TB, outcome is highly dependent on rifampicin (RIF) dose/concentrations. It is known that RIF CSF/plasma ratio is only about 0.1. According to standard WHO guidelines, treatment regimen for TBM is 2HRZE/7RH. Ethambutol does not penetrate into the CSF; meanwhile RIF dose is same as for pulmonary TB. In all of history, only one clinical trial was in pediatric TBM

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