An observational study in Skin Diseases, Bacterial and Skin Diseases, Infectious, sponsored by Angelini Farmacéutica. Completed at 7 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-22.
Sponsored by Angelini Farmacéutica · Observational
The aim of this study is to describe the real clinical use of Dalbavancin in Spain between January 2018 and December 2019.
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.
Patients treated with dalbavancin from 1st January 2018 to 31st December 2019
Exclusion Criteria:
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.
Demographic and clinical characteristics of patients treated with dalbavancin
To describe the demographic and clinical characteristics of patients treated with dalbavancin (primary objective)
Time frame: 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)
Time frame: patients treated with dalbavancin between January 2018 and December 2019
Effectiveness/Clinical response
Clinical response (signs and symptoms) evaluated at the end of treatment
Time frame: From 48-72h after the end of treatment until 90 days after last dose of dalbavancin
Effectiveness/Relapse
Relapse (Yes/No)
Time frame: 90 days after after last dose of dalbavancin
Safety. Adverse events
Rate of adverse events Rate of treatment discontinuation due to Adverse events
Time frame: From first dose until 90 days after last dose of dalbavancin
Treatment compliance
Patient received the full dose of dalbavancin (Yes/No)
Time frame: : 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
Time frame: 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)
Time frame: From first dose until 90 days after last dose of dalbavancin
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Angelini Farmacéutica