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
