Multicenter clinical experience of real life Dalbavancin use in gram-positive infections

Abstract

Dalbavancin, a lipoglycopeptide with prolonged half-life approved for the treatment of acute bacterial skin and soft tissue infections, can be used for the treatment of infections caused by gram-positive bacteria requiring long term treatment such as endocarditis, prosthetic joint infections (PJI) or osteomyelitis. Clinical data are limited in these settings. Objectives: To evaluate indications, safety, tolerability and long-term outcomes of dalbavancin-treated patients.Patients and methods Our multicenter, retrospective study includes patients who received dalbavancin in Austria from September 2016 to March 2018. 90-day outcomes and tolerability were determined. Results: A total of 101 patients were included in 3 centers (57% male, median age 65 years). The treated infections were PJI (31%), osteomyelitis (29%), endocarditis (25%) and acute bacterial skin and soft tissue infections (12%). Concomitant use of other antimicrobial substances was common (63%). The mean total cumulative dose of dalbavancin was 3,357 mg (AE2,283 mg). Clinical success rate was 89%. Side effects occurred in 3/101 patients. Conclusion:In this real-life study dalbavancin was primarily used in off-label indications for treatment of PJI, osteomyelitis and endocarditis. Success rate was high (89%), tolerability and safety were excellent in this setting. Dalbavancin may therefore be used in these off-label indications as alternative treatment approach.

Real-world experience with dalbavancin therapy in gram-positive skin and soft tissue infection, bone and joint infection

“…The incidence of adverse events observed in this study was similar to that reported in randomized, controlled clinical trials and in real-life reports [7,8,16,19,21]. In our experience, dalbavancin had an excellent safety profile with no significant drug interactions.…”

“…The main results of our study were that we found good safety of dalbavancin for short-and long-term treatment and high clinical cure rates in acute infection including erysipelas, acute septic arthritis, acute vertebral osteomyelitis, and acute osteomyelitis, but limited treatment success among chronic infections, particularly in cases with insufficient source control. In the last 3 years, several studies reported experiences with dalbavancin use [7,8,19,21]. In the present work, the overall clinical cure rate (64%) under dalbavancin was lower compared with previous reports (84.1% by Bouza et al and 89.5% by Wunsch et al) [8,19].…”

“…In the last 3 years, several studies reported experiences with dalbavancin use [7,8,19,21]. In the present work, the overall clinical cure rate (64%) under dalbavancin was lower compared with previous reports (84.1% by Bouza et al and 89.5% by Wunsch et al) [8,19]. Noteworthy, in our case series, dalbavancin was used mainly as salvage treatment (54%) due to missing clinical success of the prior antimicrobial regimen and in off-label indications (54 patients, 75%).…”

“…The approved dosage for dalbavancin for adults with ABSSSIs is a two-dose regimen of 1000 mg on day 1 followed by 500 mg on day 8 and single use of 1500 mg [3,8,16]. Due additionally, dalbavancin doseregimens used in our university hospital include a two-dose regimen of 1500 mg on day 1 followed by 1000 mg on day 14 [17,18], and a two dose-regimen of 1500 mg on day 1 followed by 1500 mg on day 8 [7,16,19,20]. The prolonged use of dalbavancin for several weeks is well established in our clinical setting [7].…”

New Answers for Old Questions in the Treatment of Severe Infections from Injection Drug Use

“…Currently, both are approved by the United States Food and Drug Administration only for skin and skin structure infections, but there are increasing reports of successful use in more severe infections including osteomyelitis, bacteremia, and endocarditis. [39][40][41][42] Two studies of dalbavancin in vulnerable populations, including primarily IDU-associated infections, found a somewhat unimpressive 56% and 71% clinical response and success rate, respectively. Without comparison groups, one cannot conclude that patients would have done any better with traditional OPAT or long-term hospitalization.…”