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 (part of Angelini Pharma) · 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.
37 studies on the registry are indexed under Skin Diseases, Bacterial; 2 are open to participants now.
Browse Skin Diseases, Bacterial studies →Angelini Farmacéutica is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients treated with dalbavancin from 1st January 2018 to 31st December 2019
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Ran from Jul 2020 to primary completion in Dec 2020, 5 months.
How these figures are worked out, and which studies are left out of them.
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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