Real-World Use of Dalbavancin in the Era of Empowerment of Outpatient Antimicrobial Treatment: A Careful Appraisal Beyond Approved Indications Focusing on Unmet Clinical Needs

Milo Gatti,1,2 Massimo Andreoni,3,4 Federico Pea,1,2 Pierluigi Viale1,5 1Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy; 2SSD Clinical Pharmacology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; 3Department of Systems Medicine, University of Rome “Tor Vergata”, Rome, Italy; 4Infectious Diseases Clinic, University Hospital “Tor Vergata”, Rome, Italy; 5Infectious Disease Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, ItalyCorrespondence: Milo GattiDepartment of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Via Massarenti 9, Bologna, 40138, ItalyTel +39 051 214 3627Email milo.gatti2@unibo.itAbstract: Dalbavancin is a novel, long-acting lipoglycopeptide characterized by a long elimination half-life coupled with excellent in vitro activity against multidrug-resistant Gram-positives. Although it is currently approved only for the treatment of acute bacterial skin and skin structure infections, an ever-growing amount of evidence supports the efficacy of dalbavancin as a long-term therapy in osteomyelitis, prosthetic joint infections, endocarditis, and bloodstream infections. This article provides a critical reappraisal of real-world use of dalbavancin for off-label indications. A search strategy using specific keywords (dalbavancin, osteomyelitis, endocarditis, long-term suppressive therapy, bloodstream infection, pharmacokinetic/pharmacodynamic profile) until April 2021 was performed on the PubMed-MEDLINE database. As for other novel antibiotics, a conundrum between approved indications and potential innovative therapeutic uses has emerged for dalbavancin as well. The promising efficacy in challenging scenarios (i.e., osteomyelitis, endocarditis, prosthetic joint infections), coupled with the unique pharmacokinetic/pharmacodynamic properties, makes dalbavancin a valuable alternative to daily in-hospital intravenous or outpatient antimicrobial regimens in the treatment of long-term Gram-positive infections. This makes dalbavancin valuable in the current COVID-19 scenario, in which hospitalization and territorial medicine empowerment are unavoidable.Keywords: dalbavancin, osteomyelitis, endocarditis, long-term suppressive therapy, PK/PD properties, COVID-19