Phase 2 High-dose Rifampicin for the Treatment of Tuberculous Meningitis: a Dose-finding Study (ReDEFINe)

Study Director
Rovina Ruslami
Start Date
7 / 2014
Trial Phase
Phase II
Trial Status
in data analysis
Current Enrollment
60 (May 2017)
Target Enrollment

ReDEFINe study - (Rifampicin Dose Finding Study), a double blind randomized control trial phase IIb Clinical Trial, funded by USAID & NIH through PEER Health program (NCT02169882) Hasan Sadikin General Hospital, Bandung, Jawa Barat, Indonesia, 40161

Active Comparator: Rifampicin 450 mg (standard dose)

Experimental: Rifampicin 900 mg per oral

Experimental: Rifampicin 1350 mg per oral

Along with study drug and placebo, patients received other oral TB drugs (INH, Ethambutol, and Pyrazinamide) and pyridoxin, in accordance to National TB Program guidelines for 6 months. Patients also received dexamethasone in decreasing dose (in 6-8 weeks, according to TBM severity grade on admission)

Compound Associations