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 , DOI: 10.1080/14787210.2020.1798227
Francesca Bai ₁ , Chiara Aldieri ₁ , AnnaMaria Cattelan ₂ , Francesca Raumer ₂ , Eugenia Di Meco ₂ , Maria Cristina Moioli ₃ , Federica Tordato ₄ , Paola Morelli ₄ , Federica Borghi ₅ , Marco Rizzi ₅ , Evelyn Van Hauwermeiren ₆ , Francesco Castelli ₆ , Guglielmo Migliorino ₇ , Barbara Menzaghi ₈ , Giuliano Rizzardini ₉ , Annalisa Saracino ₁₀ , Antonio Cascio ₁₁ , Massimo Puoti ₃ , Antonella d'Arminio Monforte ₁ , Giulia Marchetti ₁

Affiliation

Clinic of Infectious Diseases, San Paolo Hospital, ASST Santi Paolo E Carlo, University of Milan , Milan, Italy.
Clinic of Infectious Diseases, Department of Internal Medicine, University Hospital of Padua , Padua, Italy.
Clinic of Infectious Diseases, ASST Grande Ospedale Metropolitano Niguarda , Milan, Italy.
Infectious Diseases Unit, Hospital Health Direction, Humanitas Clinical and Research Center , Milan, Italy.
Infectious Diseases Unit, ASST Papa Giovanni XXIII, Bergamo Hospital , Bergamo, Italy.
Infectious Diseases Unit, Department of Clinical and Epidemiological Science, ASST Spedali Civili, University of Brescia , Brescia, Italy.
Infectious Diseases Unit, San Gerardo Hospital , Monza, Monza E Brianza, Italy.
Infectious Diseases Unit, ASST Valle Olona, Busto Arsizio Hospital , Busto Arsizio, Varese, Italy.
Department of Infectious Diseases, ASST Fatebenefratelli, Luigi Sacco Hospital , Milan, Italy.
University of Bari 'Aldo Moro', Clinic of Infectious Diseases, Department of Biomedical Sciences and Human Oncology, University of Bari , Bari, Italy.
Dipartimento Di Promozione Della Salute, Materno-Infantile, Di Medicina Interna E Specialistica Di Eccellenza "G. D'Alessandro", University of Palermo , Palermo, Italy.

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：

达巴万星在现实环境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。