Efficacy and safety of dalbavancin in the treatment of acute bacterial skin and skin structure infections (ABSSSIs) and other infections in a real-life setting: data from an Italian observational multicentric study (DALBITA study)

Abstract

(2020): Efficacy and safety of dalbavancin in the treatment of acute bacterial skin and skin structure infections (ABSSSIs) and other infections in a real-life setting: data from an Italian observational multicentric study (DALBITA study), Expert Review of Anti-infective Therapy,

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

“… Range median MIC 0.032–0.064 mg/L NA Clinical cure: 100.0% (BSI) Relapse: 4% (overall) 6.7% (not serious) Bouza et al, 2018 37 Retrospective cohort study, multicentric 10 8 CR-BSI 2 other endovascular infections OPAT 73.9% 97.1% (median 18 days) Dalbavancin 1500 mg single dose or 1000 mg (LD) + 500 mg 4 MRSA 3 CoNS 2 MSSA 2 Enterococcus spp. NA Clinical success: 80.0% Mortality rate: 10.0% Relapse: 0.0% 13.0% (2.9% serious) Bork et al, 2019 41 Retrospective cohort study, multicentric 10 (28 overall patients included in the study) 6 Endovascular 4 BSI OPAT 100% 100.0% (median 13.5 days) NA 8 MRSA 6 MSSA 4 CoNS 8 Other 5 NA 30–90 days Overall clinical success: 71% (BSI 60% at 30-day) NA 10.7% (overall) Nunez-Nunez et al, 2018 40 Prospective observational 5 (19 overall patients included in the study) OPAT 65% 100% Dalbavancin 1500 mg single dose or 1500 mg + 1500 mg or 1000 mg + 500 mg 7 MRSA 6 CoNS 5 MSSA 1 E. faecalis 1 E. faecium 90 days Clinical success: 100.0% Relapse: 0.0% 4.5% (not serious; overall) Bai et al, 2020 38 Retrospective cohort study, multicentric …”

“…Overall, AEs were reported in only 3% of cases. Interestingly, Bai et al 38 stratified clinical outcome according to different type of bone and joint infection in 50 patients receiving dalbavancin (1500 mg single dose or 1000 mg LD followed by 500 mg at day 8). At 6 months, clinical success was respectively reported in 89.7% of osteomyelitis/spondylodiscitis, 76.5% of prosthetic joint infections, and 75% of septic arthritis.…”

“… 5 Streptococcus spp. 4 P. acnes 21 Others 90 days after the last dose of dalbavancin Overall clinical success: 89% (93.6% bone and joint infections) 90-day mortality rate: 5% (3.2% bone and joint infections) Overall clinical failure: 5% (3.2% bone and joint infections) NA 3% (overall) Bai et al, 2020 38 Retrospective cohort study, multicentric 50 (82 overall patients included in the study) 25 Osteomyelitis 17 Prosthetic joint infections 4 Spondylodiscitis 4 Septic arthritis OPAT 57.8% 82.5% Dalbavancin 1000 mg (LD) + 500 mg or 1500 mg single dose 28 CoNS 24 MRSA 14 MSSA 6 E. faecalis 5 E. faecium 5 Others 30–180 days Clinical success at end of study: 89.7% (osteomyelitis – spondylodiscitis) 76.5% (prosthetic joint infections) 75.0% (septic arthritis) Relapse: 17.8% (overall in the study) 7.0% Dinh et al, 2019 34 Retrospective cohort study, multicentric 48 (75 overall patients included in the study OPAT 49.3% 98.7% Dalbavancin 1000–1500 mg single-dose or 1000 mg + 500 mg or 1000 mg + 1000 mg or 1500 mg/weekly up to > 4 doses 32 CoNS 23 MSSA 14 MRSA 5 E. faecalis 5 Corynebacterium spp. Range median MIC 0.032–0.064 mg/L NA Clinical cure: 76.1% (bone and joint infections) Relapse: 4% (overall) 6.7% (not serious) Tobudic et al, 2019 53 Retrospective cohort study 46 (72 overall patients included in the study) 20 Osteomyelitis 14 Spondylodiscitis 8 Prosthetic joint infections 4 Acute septic arthritis ...…”

Dalbavancin Efficacy and Impact on Hospital Length-of-Stay and Treatment Costs in Different Gram-Positive Bacterial Infections

“…Studies published thus far have investigated the efficacy, safety, and tolerability of dalbavancin [14,15], but only a few of them have attempted to assess its impact on hospital LOS and treatment-related costs, mainly with the following approaches: (a) systematic reviews, network meta-analysis, and cost analysis of data from the current literature [16]; (b) description of therapeutic strategies performed in real-life settings that have included dalbavancin and estimation of the related economic advantages/disadvantages [17][18][19]; (c) expense simulation models based on data collected in a real-life scenario, performed with a mono-or multi-centric design [20,21].…”

“…Although providing remarkable insights, these studies were still affected by different limitations: some of them were based on simulation models rather than on a real-life approach [20,21]; others considered ABSSSI as the sole infection studied [16][17][18]; in some researchs, patient enrollment was performed from a single specialty Unit [18,21]; in other reports, cost analysis was based on a generic estimated, rather than individually calculated, cost of standard therapy in medical units [19][20][21].…”