Abstract:
Background: Long-acting lipoglycopeptides (LALs), including dalbavancin and oritavancin, may facilitate outpatient-oriented management of Gram-positive infections by reducing the need for prolonged hospitalization and daily intravenous therapy. However, real-world evidence on their use in day hospital pathways, particularly for complex off-label infections, remains limited. This study evaluated the clinical effectiveness, safety, and economic impact of LAL-based day hospital management, comparing in-label acute bacterial skin and skin-structure infections (ABSSSI) with complex off-label indications.
Methods: This retrospective, multicenter observational study included 160 adult patients treated with dalbavancin and/or oritavancin in a day hospital setting across nine Italian centers between January 2020 and December 2025. Indications were classified as in-label ABSSSI or off-label infections, including osteomyelitis, prosthetic joint infection, spondylodiscitis, endocarditis, septic arthritis, and prosthetic cardiac infection. The primary endpoint was clinical success at final follow-up. Secondary endpoints included adverse drug events, readmissions, inflammatory marker response, and a budget impact cost-offset analysis based on avoided inpatient bed-days.
Results: Overall, 54.4% of patients received LALs for off-label indications, mainly osteomyelitis, prosthetic joint infection, and spondylodiscitis. Clinical outcome was available for 159 patients, with an overall success rate of 86.8% (138/159). Success rates were 90.4% for in-label ABSSSI and 83.7% for off-label indications, with no statistically significant difference between groups (p = 0.247). In exploratory analyses, monotherapy was associated with lower failure odds; this most likely reflects confounding by indication and should not be interpreted as a treatment effect. Inflammatory markers significantly decreased from baseline to end of therapy. Adverse drug events were uncommon (3.3%), mild, and did not lead to treatment discontinuation. In a scenario-based cost-offset model (no matched inpatient comparator), the strategy corresponded to 1107-2214 avoided inpatient bed-days; estimated net savings ranged from approximate cost-neutrality under conservative assumptions (€11,976) to €676,176 under maximum assumptions, and one-way sensitivity analysis showed a possible net loss at low inpatient daily-cost values-underscoring that these are modeled rather than observed savings.
Conclusions: In this uncontrolled, retrospective cohort, LAL-based day hospital management was feasible and associated with favorable observed clinical outcomes, an acceptable safety profile, and a potential for cost offset in selected patients with Gram-positive infections, including complex off-label indications. Because no matched inpatient or conventional OPAT comparator was included, these findings should be regarded as hypothesis-generating and cannot establish comparative efficacy, superiority, or actual cost savings.
Reference:Marino A, Venanzi Rullo E, Pipitone G, Geremia AG, De Vito A, Albanese A, Geremia N, Franzò A, Cosentino F, Italia P, Ciuppa ME, Buzzi A, Santoro L, Iaria C, Madeddu G, Iacobello C, Manuele R, Pulvirenti F, Cacopardo B, Nunnari G. Saving Beds and Budgets: Real-World Efficacy, Safety, and Pharmacoeconomics of Long-Acting Lipoglycopeptides (LALs) in a Day Hospital Setting. Pathogens. 2026 Jul 14;15(7):740. doi: 10.3390/pathogens15070740. PMID: 42515067; PMCID: PMC13414768.