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NCT04485676 Clinical Trial

Dalbavancin in Real Clinical Practice in Spain

Skin Diseases, Infectious Clinical Trial

— REAL-DAL  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04485676
Other study ID # ANG-DAL-2019-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 15, 2020
Est. completion date February 21, 2021

Study information
Verified date May 2021
Source Angelini Farmacéutica
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 187
Est. completion date February 21, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Spain Hospital Universitario A Coruña A Coruña
Spain Hospital Clínic Barcelona Barcelona
Spain Hospital Universitari Vall d'Hebrón Barcelona
Spain Hospital Universitario Virgen de las Nieves Granada
Spain Hospital General Universitario Gregorio Marañón Madrid
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universtario La Fe Valencia

Sponsors (2)
Lead Sponsor Collaborator
Angelini Farmacéutica Effice Servicios Para la Investigacion S.L.

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary Effectiveness/Relapse Relapse (Yes/No) 90 days after after last dose of dalbavancin
Secondary 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
Secondary Treatment compliance Patient received the full dose of dalbavancin (Yes/No) : From first dose until 90 days after last dose of dalbavancin
Secondary 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
Secondary 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
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