Claudia Bartalucci, Daniele Roberto Giacobbe, Marco Muccio, Silvia Sisto, Lorenzo Costacurta, Alessandro Limongelli, Chiara Aldieri, Alessandra Bandera, Samuele Cantergiani, Annamaria Cattelan, Luca Ceccarelli, Andrea Cortegiani, Gennaro De Pascale, Giuseppe Vittorio Luigi De Socio, Valerio Del Bono, Filippo Del Puente, Stefano Di Bella, Chiara Fanelli, Erica Franceschini, Nicholas Geremia, Mariachiara Ippolito, Andrea Lombardi, Ivana Maida, Maria Mazzitelli, Marco Merli, Alessandra Mularoni, Carlo Pallotto, Sandro Panese, Francesca Pecoraro, Emanuele Pontali, Matteo Rinaldi, Maurizio Sanguinetti, Vincenzo Scaglione, Carlo Torti, Giovanna Travi, Verena Zerbato, Vincenzo Di Pilato, Paola Morici, Anna Marchese, Mauro Giacomini, Malgorzata Mikulska, Antonio Vena, Matteo Bassetti, AMPHO-SITA investigators
L-AmB remains an important antifungal option in real-life, across diverse clinical scenarios and in heterogeneous patient populations with substantial comorbidity and clinical severity, while overall retaining a manageable safety profile.
BACKGROUND: Invasive fungal diseases (IFDs) cause significant morbidity and mortality, and liposomal amphotericin B (L-AmB) is a key treatment option for both IFDs and visceral leishmaniasis. Despite extensive clinical experience, real-world data on L-AmB use across diverse clinical settings remain limited.
METHODS: The AMPHO-SITA study was a multicenter, retrospective observational study conducted across 14 Italian centers (September 2020-October 2024). Adult patients receiving at least one dose of L-AmB were included. Baseline demographics, comorbidities, infection and L-AmB treatment characteristics, and outcomes were collected. IFDs were classified according to EORTC/MSGERC and FUNDICU definitions, and visceral leishmaniasis according to international guidelines. Primary descriptive endpoints were patient characteristics, infection characteristics, 30-day mortality, and 90-day mortality. Secondary analyses assessed factors associated with mortality using multivariable Cox regression models.
RESULTS: Among 389 patients (median age 61 years; 37.8% female), 41.3% had hematological malignancies and 52.4% required ICU admission. L-AmB was administered empirically in 53.0%, as targeted therapy in 47.0% of cases, and as combination therapy in 12.4%. Proven or probable IFDs were diagnosed in 52.2% of patients; visceral leishmaniasis was diagnosed and treated in 4.1%. Cumulative 30-day and 90-day mortality for IFD patients were 35.7% (95% confidence interval [CI] 28.5-42.9) and 61.4% (95% CI 51.8-69.6), respectively. NYHA score and SOFA score showed an independent association with both 30-day and 90-day mortality in multivariable models.
CONCLUSIONS: L-AmB remains an important antifungal option in real-life, across diverse clinical scenarios and in heterogeneous patient populations with substantial comorbidity and clinical severity, while overall retaining a manageable safety profile.