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| Name | Class |
|---|---|
| Effice Servicios Para la Investigacion S.L. | INDUSTRY |
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The aim of this study is to describe the real clinical use of Dalbavancin in Spain between January 2018 and December 2019.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Effectiveness/Relapse |
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Inclusion Criteria:
Exclusion Criteria:
1. Patient enrolled in a clinical trial in which treatment with dalbavancin is managed through a protocol
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Patients treated with dalbavancin from 1st January 2018 to 31st December 2019
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| Name | Affiliation | Role |
|---|---|---|
| Benito Almirante, PhD | Hospital Vall d'Hebrón | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario A Coruña | A Coruña | 15006 | Spain | |||
| Hospital Universitari Vall d'Hebrón |
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| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D012874 | Skin Diseases, Infectious |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012871 | Skin Diseases |
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Relapse (Yes/No)
| 90 days after after last dose of dalbavancin |
| 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 |
| Treatment compliance | Patient received the full dose of dalbavancin (Yes/No) | : From first dose until 90 days after last dose of dalbavancin |
| 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 |
| 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 |
| Barcelona |
| 08035 |
| Spain |
| Hospital Clínic Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario Virgen de las Nieves | Granada | 18014 | Spain |
| Hospital General Universitario Gregorio Marañón | Madrid | 28007 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universtario La Fe | Valencia | 46026 | Spain |
| D017437 |
| Skin and Connective Tissue Diseases |