Dalbavancin in Real Clinical Practice in Spain (REAL-DAL)

Angelini Pharma

Status: Completed

Conditions: Skin Diseases, Infectious; Skin Diseases, Bacterial

Study type: Observational

Funder types: Industry

Identifiers

NCT04485676

ANG-DAL-2019-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 187 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

187 participants in 1 patient group

Dalbavancin

Description:

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.