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. 2024 Aug;52(4):1297-1306.
doi: 10.1007/s15010-024-02176-2. Epub 2024 Feb 7.

In-label, off-label prescription, efficacy and tolerability of dalbavancin: report from a National Registry

Silvano Esposito  1 , Pasquale Pagliano  2 , Giuseppe De Simone  2 , Amedeo Guarino  3 , Angelo Pan  4 , Paola Brambilla  4 , Claudio Mastroianni  5 , Miriam Lichtner  6 , Pierluigi Brugnaro  7   8 , Anna Carretta  7   8 , Teresa Santantonio  7   8 , Gaetano Brindicci  9 , Giuliana Carrega  10 , Francesca Montagnani  11 , Giuseppe Lapadula  12 , Anna Spolti  12 , Roberto Luzzati  13 , Elisabetta Schiaroli  14 , Vittoria Scaglione  14 , Carlo Pallotto  15 , Danilo Tacconi  15 , Francesco Quintieri  16 , Enrico Trecarichi  16 ; Italian Society of Infectious, Tropical Diseases
Affiliations

In-label, off-label prescription, efficacy and tolerability of dalbavancin: report from a National Registry

Silvano Esposito et al. Infection. 2024 Aug.

Abstract

Purpose: Although dalbavancin is currently approved for the treatment of ABSSIs, several studies suggest its efficacy and tolerance as long-term therapy for other off-label indications requiring prolonged intravenous antibiotic administration.

Methods: We conducted a prospective nationwide study of dalbavancin use in real-life settings for both approved and off-label indications analysing for each case the clinical and microbiological characteristics of infection the efficacy and safety of treatments.

Results: During the study period (from December 2018 to July 2021), the ID specialists from 14 different centres enrolled 223 patients treated with dalbavancin [141 males (63%) and 82 females (37%); male/female ratio 1.72; mean age 59 (SD 17.2) years, (range 15-96). Most patients in the study population (136/223; 61.0%) came from community rather than health care facilities and most of them were visited in Infectious Diseases wards (93/223; 41.7%) and clinics (55/223; 24.7%) even though some patients were cured in other settings, such as surgery wards (18/223; 8.1%), orthopaedic wards (11/223; 4.9%), Emergency Rooms (7/223; 3.1%) and non-surgical other than ID wards (6/223; 2.7%). The most common ID diagnoses were osteomyelitis (44 cases/223; 19.7%; of which 29 acute and 15 chronic osteomyelitis), cellulitis (28/223; 12.5%), cutaneous abscess (23/223; 10.3%), orthopaedic prosthesis-associated infection (22/223; 9.9%), surgical site infection (20/223; 9.0%) and septic arthritis (15/223; 6.7%).

Conclusion: In conclusion, by virtue of its PK/PD properties, dalbavancin represents a valuable option to daily in-hospital intravenous or outpatient antimicrobial regimens also for off-label indications requiring a long-term treatment of Gram-positive infections.

Keywords: Dalbavancin; In-label; Off-label.

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Conflict of interest statement

None to declare.

Figures

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Fig. 1
Anatomical sites of infectious diseases diagnosed
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Fig. 2
Previous antibiotic therapy administrated as mono-therapy
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Fig. 3
Previous antibiotics administrated as association-therapy
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Fig. 4
Antimicrobial molecules administrated in association with dalbavancin
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Fig. 5
Length of hospital stay
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