Dalbavancin in Real Clinical Practice in Spain

Completed

• Conditions: Skin Diseases, Bacterial; Skin Diseases, Infectious

• Registration Number: NCT04485676
• Lead Sponsor: Angelini Farmacéutica

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 Timeline

• Study First Submitted: 2020-06-16
• Study Start: 2020-07-15
• Study First Submitted QC: 2020-07-21
• Study First Posted: 2020-07-24
• Primary Completion: 2020-12-31
• Study Completion: 2021-02-21
• Status Verified: 2021-05
• Last Update Submitted: 2022-07-21
• Last Update Posted: 2022-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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/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
Effectiveness/Relapse	90 days after after last dose of dalbavancin	Relapse (Yes/No)
Treatment compliance	: From first dose until 90 days after last dose of dalbavancin	Patient received the full dose of dalbavancin (Yes/No)
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)
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

Trial Locations

Locations (7)

Hospital Universitario Virgen de las Nieves; 🇪🇸 Granada, Spain

Hospital Universitari Vall d'Hebrón; 🇪🇸 Barcelona, Spain

Hospital Universitario A Coruña; 🇪🇸 A Coruña, Spain

Hospital General Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Clínic Barcelona; 🇪🇸 Barcelona, Spain

Hospital Universtario La Fe; 🇪🇸 Valencia, Spain