Table 1.
Study | Treatment Regimen | Main Results | Reference | |||
---|---|---|---|---|---|---|
Murine model of | ||||||
• systemic candidiasis | CAmB vs. DAmB | • 100% survival at CAmB 0.5 mg/kg/day equivalent to DAmB 2 mg/kg/day. | [10] | |||
• dose-dependent reduction of CFU in kidney and lungs. | ||||||
• cryptococcal meningitis | CAmB + 5FC vs. DAmB + 5FC | • CAmB 25 mg/kg/day + 5FC equivalent to DAmB 5 mg/kg/day + 5FC. | [17] | |||
• Comparable brain tissue levels between CAmB and DAmB. | ||||||
• invasive aspergillosis | CAmB vs. DAmB | • Dose dependent reduction of CFU and mortality. | [16] | |||
• Survival rate of 70% at CAmB 20 and 40 mg/kg/day. | ||||||
Clinical trials | ||||||
• Phase IIA, CMC | CAmB | • Improvement of symptoms in 50%–85% at CAmB 400–800 mg. | [19] | |||
• AE: nausea, dizziness. | ||||||
• No organ disorders. | ||||||
• Phase II, VVC | CAmB vs. fluconazole | CAmB 200 mg | CAmB 400 mg | Fluconazole 150 mg | [20] | |
Clinical cure | 52 % | 55 % | 75 % | |||
Mycological response | 36 % | 32 % | 84 % | |||
Overall response | 16 % | 14 % | 69 % | |||
non-serious AE | 22 % | 27 % | 9 % |
CAmB, encochleated amphotericin b (MAT2203); DAmB, amphotericin deoxycholate; CFU, colony forming unit; 5FC, flucytosine; CMC, chronic mucocutaneous candidiasis; VVC, vulvovaginal candidiasis; AE, adverse events.