To evaluate the safety and efficacy of liposomal amphotericin B and amphotericin B deoxycholate with or without flucytosine followed by fluconazole for the treatment of cryptococcal meningitis.
Subjects who meet all eligible requirements will be randomized into study group (Lipo-AB)or control group(Amphotericin B deoxycholate) in 2:1 ratio. Subjects will be treated with induction therapy in study group or in control group with flucytosine for at least 14 days, and followed by consolidation therapy for another 56 days after CSF sterilization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
4mg/kg/day, IV infusion
1mg/kg/day, IV infusion
National Taiwan University Hospital
Taipei, Taiwan
RECRUITINGsuscceful response rate
Successful response was defined as both satisfactory clinical and microbiological response at the completion of 14 days treatment period.
Time frame: Day 14
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