Dalbavancin in Real Clinical Practice in Spain

Study Overview
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Brief Summary
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The aim of this study is to describe the real clinical use of Dalbavancin in Spain between January 2018 and December 2019.

Detailed Description
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Dalbavancin is a new lipoglycopeptide approved for the treatment of ABSSSIs (Acute Bacterial Skin and Skin-Structure Infections) with activity against Gram-positive pathogens, including MRSA. Dalbavancin has unique pharmacokinetics properties, with a terminal half-life of 14.4 days, permitting a single intravenous dosing. Dalbavancin has shown a favourable efficacy and safety profile in patients with ABSSSI in randomized controlled trials. However, information regarding daily clinical practice is limited. The main objective of this study is to describe the real clinical practice with Dalbavancin in Spain.

Official Title
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Dalbavancin in Real Clinical Practice in Spain: a Two-year Retrospective Study

Conditions
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Skin Diseases, Bacterial, Skin Diseases, Infectious

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult man and woman (≥ 18 years) at the time of receiving dalbavancin Patients receiving at least one dose of dalbavancin between 1st January 2018 and 31st December 2019 Patients with medical follow-up information registered in clinical records for about 90 days after completing the treatment Written informed consent requested according to local regulation, IEC and protocol requirements Exclusion Criteria: 1. Patient enrolled in a clinical trial in which treatment with dalbavancin is managed through a protocol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dalbavancin<br>Patients to be included in this study have been treated with Dalbavancin according to clinician's judgement and clinical practice according national or international guidelines. Dalbavancin is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. Information about dosing treatment will be collected. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic and clinical characteristics of patients treated with dalbavancin | To describe the demographic and clinical characteristics of patients treated with dalbavancin (primary objective) | patients treated with dalbavancin between January 2018 and December 2019 | 
| Variables related to dalbavancin treatment | To describe the demographic and clinical characteristics of patients treated with dalbavancin (primary objective) | patients treated with dalbavancin between January 2018 and December 2019 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness/Clinical response | Clinical response (signs and symptoms) evaluated at the end of treatment | From 48-72h after the end of treatment until 90 days after last dose of dalbavancin | 
| Effectiveness/Relapse | Relapse (Yes/No) | 90 days after after last dose of dalbavancin | 
| Safety. Adverse events | Rate of adverse events Rate of treatment discontinuation due to Adverse events | From first dose until 90 days after last dose of dalbavancin | 
| Treatment compliance | Patient received the full dose of dalbavancin (Yes/No) | : From first dose until 90 days after last dose of dalbavancin | 
| Doctors opinion on infection management with dalbavancin (1) | Degree of physician satisfaction on management with dalbavancin: Dissatisfied, Little satisfied, Satisfied, Very satisfied | From first dose until 90 days after last dose of dalbavancin | 
| Doctors opinion on infection management with dalbavancin (2) | Physician assessment on potential reduction in the number of days of hospital stay (Yes/No) | From first dose until 90 days after last dose of dalbavancin |