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Completed

NCT Number: NCT04485676

Dalbavancin in Real Clinical Practice in Spain

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

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Key information

Conditions

Skin Diseases, Bacterial Bacterial Infections Bacterial Infections and Mycoses Infections Skin Diseases Skin Diseases, Infectious Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario A Coruña, A Coruña, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Demographic and clinical characteristics of patients treated with dalbavancin

    Time frame: patients treated with dalbavancin between January 2018 and December 2019

    To describe the demographic and clinical characteristics of patients treated with dalbavancin (primary objective)

  2. Variables related to dalbavancin treatment

    Time frame: 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 outcomes

  1. Effectiveness/Clinical response

    Time frame: 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

  2. Effectiveness/Relapse

    Time frame: 90 days after after last dose of dalbavancin

    Relapse (Yes/No)

  3. Safety. Adverse events

    Time frame: From first dose until 90 days after last dose of dalbavancin

    Rate of adverse events Rate of treatment discontinuation due to Adverse events

  4. Treatment compliance

    Time frame: : From first dose until 90 days after last dose of dalbavancin

    Patient received the full dose of dalbavancin (Yes/No)

  5. Doctors opinion on infection management with dalbavancin (1)

    Time frame: 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

  6. Doctors opinion on infection management with dalbavancin (2)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Angelini Farmacéutica

Industry

Collaborators

  • Effice Servicios Para la Investigacion S.L.

Registry information

Official study title

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

Acronym: REAL-DAL

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jul 24, 2020
Registry last updated
Jul 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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