Clinical trial NCT04485676: Dalbavancin in Real Clinical Practice in Spain
Official title: Dalbavancin in Real Clinical Practice in Spain: a Two-year Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Diseases, Bacterial
Skin Diseases, Infectious
Lead sponsor: Angelini Farmacéutica
Sponsor class: INDUSTRY
Collaborators: name: Effice Servicios Para la Investigacion S.L.
First posted: 2020-07-24
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with dalbavancin from 1st January 2018 to 31st December 2019

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Demographic and clinical characteristics of patients treated with dalbavancin
timeFrame: patients treated with dalbavancin between January 2018 and December 2019
measure: Variables related to dalbavancin treatment
timeFrame: patients treated with dalbavancin between January 2018 and December 2019
Secondary outcomes:
measure: Effectiveness/Clinical response
timeFrame: From 48-72h after the end of treatment until 90 days after last dose of dalbavancin
measure: Effectiveness/Relapse
timeFrame: 90 days after after last dose of dalbavancin
measure: Safety. Adverse events
timeFrame: From first dose until 90 days after last dose of dalbavancin
measure: Treatment compliance
timeFrame: : From first dose until 90 days after last dose of dalbavancin
measure: Doctors opinion on infection management with dalbavancin (1)
timeFrame: From first dose until 90 days after last dose of dalbavancin
measure: Doctors opinion on infection management with dalbavancin (2)
timeFrame: From first dose until 90 days after last dose of dalbavancin
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: Hospital Universitario A Coruña
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebrón
city: Barcelona
country: Spain
facility: Hospital Clínic Barcelona
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Valencia
country: Spain
facility: Hospital Universtario La Fe
Study officials:
affiliation: Hospital Vall d'Hebrón
name: Benito Almirante, PhD
role: PRINCIPAL_INVESTIGATOR
References: