Dalbavancin in Real Clinical Practice in Spain

NCT ID: NCT04485676

Last Updated: 2022-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

187 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-15

Study Completion Date

2021-02-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Skin Diseases, Bacterial Skin Diseases, Infectious

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Effice Servicios Para la Investigacion S.L.

INDUSTRY

Sponsor Role collaborator

Angelini Farmacéutica

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Benito Almirante, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Vall d'Hebrón

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Universitario A Coruña

A Coruña, , Spain

Site Status

Hospital Universitari Vall d'Hebrón

Barcelona, , Spain

Site Status

Hospital Clínic Barcelona

Barcelona, , Spain

Site Status

Hospital Universitario Virgen de las Nieves

Granada, , Spain

Site Status

Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Site Status

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

Hospital Universtario La Fe

Valencia, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ANG-DAL-2019-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dalbavancin Outpatient Pilot
NCT03982030 WITHDRAWN PHASE4