AMBITION Trial: Liposomal amphotericin B in Cryptococcal meningitis

2022 AMBITION TRIAL Single-dose liposomal amphotericin B treatment for cryptococcal meningitis Open-label, phase 3, non inferiority, randomized controlled trial M Objective: To determine the efficacy and safety of single high dose (10mg/kg) of liposomal amphotericin B in HIV-positive adults with cryptococcal meningitis 844 patients Inclusion criteria: HIV-positive adults > 18 years who had first episode of cryptococcal meningitis, diagnosed on the basis of positive India ink stain or cryptococcal antigen test of CSF sample 目 Liposomal Amphotericin B experimental regimen 24.8 (n=407) VS CONTROL: WHO recommended regimen (n=407) PRIMARY OUTCOME Death from any cause at 10 weeks % Diff -3.9; Upper boundary of 1-Sided 95% CI 1.2 28.7 P<0-001 for noninferiority SECONDARY OUTCOMES -0.40 Fungal clearance from CSF (log10 colony-forming units/ml/day) Diff 0.017; 95% CI, -0.001 to 0.036 -0.42 50.0 Grade 3 or 4 adverse events % Diff -0.4; 95% CI, -0.5 to -0.3; P<0.001 62.3 Conclusion: Single-dose liposomal amphotericin B combined with flucytosine and fluconazole was noninferior to the WHO- recommended treatment for HIV-associated cryptococcal meningitis and was associated with fewer adverse events JN Jarvis et al. NEJM 2022; 386:1109-1120 | Summary by Dr.Shreyash Bhoyar, MBBS M Visualmed