Skin Diseases, Bacterial, Skin Diseases, Infectious
Conditions
Brief summary
The aim of this study is to describe the real clinical use of Dalbavancin in Spain between January 2018 and December 2019.
Detailed description
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.
Interventions
None listed
Sponsors
Effice Servicios Para la Investigacion S.L.
Angelini Farmacéutica
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult man and woman (≥ 18 years) at the time of receiving dalbavancin 2. Patients receiving at least one dose of dalbavancin between 1st January 2018 and 31st December 2019 3. Patients with medical follow-up information registered in clinical records for about 90 days after completing the treatment 4. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demographic and clinical characteristics of patients treated with dalbavancin | patients treated with dalbavancin between January 2018 and December 2019 | To describe the demographic and clinical characteristics of patients treated with dalbavancin (primary objective) |
| Variables related to dalbavancin treatment | patients treated with dalbavancin between January 2018 and December 2019 | To describe the demographic and clinical characteristics of patients treated with dalbavancin (primary objective) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety. Adverse events | From first dose until 90 days after last dose of dalbavancin | Rate of adverse events Rate of treatment discontinuation due to Adverse events |
| Treatment compliance | : From first dose until 90 days after last dose of dalbavancin | Patient received the full dose of dalbavancin (Yes/No) |
| Effectiveness/Clinical response | From 48-72h after the end of treatment until 90 days after last dose of dalbavancin | Clinical response (signs and symptoms) evaluated at the end of treatment |
| Doctors opinion on infection management with dalbavancin (2) | From first dose until 90 days after last dose of dalbavancin | Physician assessment on potential reduction in the number of days of hospital stay (Yes/No) |
| Doctors opinion on infection management with dalbavancin (1) | From first dose until 90 days after last dose of dalbavancin | Degree of physician satisfaction on management with dalbavancin: Dissatisfied, Little satisfied, Satisfied, Very satisfied |
| Effectiveness/Relapse | 90 days after after last dose of dalbavancin | Relapse (Yes/No) |
Countries
Spain
Outcome results
None listed