Dalbavancin in Real Clinical Practice in Spain

NCT04485676 | Completed

• 1 other identifier: ANG-DAL-2019-01
• Study Type: observational
• Target: 187
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Skin Diseases, Bacterial; Skin Diseases, Infectious

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

• Safety. Adverse events

  From first dose until 90 days 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 (1)

  From first dose until 90 days after last dose of dalbavancin

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• \. Patient enrolled in a clinical trial in which treatment with dalbavancin is managed through a protocol

Sponsors & Collaborators

• Angelini Farmacéutica: lead
• Effice Servicios Para la Investigacion S.L.: collaborator

Study Sites (7)

Hospital Universitario A Coruña

A Coruña, 15006, Spain

Location

Hospital Universitari Vall d'Hebrón

Barcelona, 08035, Spain

Location

Hospital Clínic Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universtario La Fe

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Skin Diseases, Bacterial; Skin Diseases, Infectious

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Benito Almirante, PhD

  Hospital Vall d'Hebrón

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: July 24, 2020
• Study Start: July 15, 2020
• Primary Completion: December 31, 2020
• Study Completion: February 21, 2021
• Last Updated: July 22, 2022

Record last verified: 2021-05

Locations

ES (7)