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

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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 ( IF 4.2 ) Pub Date : 2020-08-14
Francesca Bai, Chiara Aldieri, AnnaMaria Cattelan, Francesca Raumer, Eugenia Di Meco, Maria Cristina Moioli, Federica Tordato, Paola Morelli, Federica Borghi, Marco Rizzi, Evelyn Van Hauwermeiren, Francesco Castelli, Guglielmo Migliorino, Barbara Menzaghi, Giuliano Rizzardini, Annalisa Saracino, Antonio Cascio, Massimo Puoti, Antonella d’Arminio Monforte, Giulia Marchetti

ABSTRACT

Objectives

We evaluated the efficacy and safety of dalbavancin in ABSSSI and ‘other sites’ infections’ (OTA).

Methods

Observational study involving 11 Italian hospitals including patients that received ≥1 dose of dalbavancin in 2016–2019. The outcome was end-of-treatment efficacy and safety in ABSSSI and OTA in a real-life setting.

Results

206 patients enrolled (males 50%, median age 62 [IQR 50–76] years), 60.2% ABSSSI, 39.8% OTA. 69.7% ABSSSI vs 90.7% OTA (p = 0.003) and 46.3% ABSSSI vs 37.2% OTA (p = 0.786) received previous and concomitant antibiotics, respectively. 82.5% reached clinical cure . Eleven (5.4%) patients had non-serious adverse events (AE). OTA patients showed longer hospitalization (13.5 days, 5.5–22 vs 3, 0–11.7; p<0.0001) and received longer previous (18 days, 9–30 vs 11, 7–19; p = 0.007)/concomitant antibiotic treatments (21 days, 14–52 vs 11, 8–14; p < 0.0001), compared to ABSSSI. ABSSSI and OTA showed similar efficacy (85.5% vs 75%, p = 0.459) and safety (no AE: 81.5% vs 64.3%, p = 0.258); efficacy was independent of previous/concomitant therapies.

Conclusions

Dalbavancin demonstrated a success rate of >80%, with similar efficacy/safety in ABSSSI and off-label indications. The preferential use of dalbavancin as second-line or combination therapy would seem to suggest the need for in-depth studies focused on its off-label use.

中文翻译：

达巴万星在现实生活中治疗急性细菌性皮肤和皮肤结构感染（ABSSSIs）和其他感染的功效和安全性：来自意大利多中心观察性研究（DALBITA研究）的数据

摘要

目标

我们评估了达巴万星在ABSSSI和“其他部位”感染（OTA）中的疗效和安全性。

方法

涉及意大利11家医院的观察性研究，包括在2016–2019年期间接受≥1剂量达巴万星的患者。结果是在现实生活中ABSSSI和OTA的治疗终了疗效和安全性。

结果

纳入206例患者（男性50％，中位年龄62 [IQR 50-76]岁），60.2％的ABSSSI，39.8％的OTA。分别接受既往和伴随抗生素治疗的分别为69.7％ABSSSI和90.7％OTA（p = 0.003）和46.3％ABSSSI对37.2％OTA（p = 0.786）。临床治愈率达82.5％。11名（5.4％）患者有非严重不良事件（AE）。OTA患者的住院时间更长（13.5天，5.5–22 vs 3，0-1-11.7； p <0.0001），以前接受的住院时间更长（18天，9–30 vs 11，7-19； p = 0.007）/同时进行抗生素治疗（与ABSSSI相比，21天，14-52 vs 11，8-14 ； p <0.0001）。ABSSSI和OTA显示出相似的功效（85.5％vs 75％，p = 0.459）和安全性（无AE：81.5％vs64.3％，p = 0.258）；疗效独立于先前/伴随的疗法。