Dalbavancin in Real Clinical Practice in Spain: a Two-year Retrospective Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 187
- Locations
- 7
- Primary Endpoint
- Demographic and clinical characteristics of patients treated with dalbavancin
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Patient enrolled in a clinical trial in which treatment with dalbavancin is managed through a protocol
Outcomes
Primary Outcomes
Demographic and clinical characteristics of patients treated with dalbavancin
Time Frame: 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
Time Frame: 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 Outcomes
- Doctors opinion on infection management with dalbavancin (1)(From first dose until 90 days after last dose of dalbavancin)
- Effectiveness/Clinical response(From 48-72h after the end of treatment until 90 days after last dose of dalbavancin)
- Effectiveness/Relapse(90 days after after last dose of dalbavancin)
- Treatment compliance(: From first dose until 90 days after last dose of dalbavancin)
- Doctors opinion on infection management with dalbavancin (2)(From first dose until 90 days after last dose of dalbavancin)
- Safety. Adverse events(From first dose until 90 days after last dose of dalbavancin)