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

Dalbavancin in Real Clinical Practice in Spain: a Two-year Retrospective Study

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

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 187

Contacts and Locations

Study Locations

• Spain
  • A Coruña, Spain, 15006
    • Hospital Universitario A Coruña
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall D'Hebron
  • Barcelona, Spain, 08036
    • Hospital Clinic Barcelona
  • Granada, Spain, 18014
    • Hospital Universitario Virgen de las Nieves
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañón
  • Valencia, Spain, 46026
    • Hospital Universtario La Fe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients treated with dalbavancin from 1st January 2018 to 31st December 2019

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Dalbavancin; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic and clinical characteristics of patients treated with dalbavancin	To describe the demographic and clinical characteristics of patients treated with dalbavancin (primary objective)	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)	patients treated with dalbavancin between January 2018 and December 2019

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness/Clinical response	Clinical response (signs and symptoms) evaluated at the end of treatment	From 48-72h after the end of treatment until 90 days after last dose of dalbavancin
Effectiveness/Relapse	Relapse (Yes/No)	90 days after after last dose of dalbavancin
Safety. Adverse events	Rate of adverse events Rate of treatment discontinuation due to Adverse events	From first dose until 90 days after last dose of dalbavancin
Treatment compliance	Patient received the full dose of dalbavancin (Yes/No)	: 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	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)	From first dose until 90 days after last dose of dalbavancin

Collaborators and Investigators

• Sponsor: Angelini Farmacéutica
• Collaborators: Effice Servicios Para la Investigacion S.L.
• Investigators: Principal Investigator: Benito Almirante, PhD, Hospital Vall d'Hebron

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): February 21, 2021

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: July 21, 2020
• First Posted (Actual): July 24, 2020

Study Record Updates

• Last Update Posted (Actual): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 21, 2022
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Skin Diseases, Infectious; Skin Diseases; Skin Diseases, Bacterial
• Other Study ID Numbers: ANG-DAL-2019-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No