title: [Methodology and aims of the European Cubicin® Outcome Registry and Experience (EUCORE) database].
abstract: The objective of most phase III, randomized controlled clinical trials with antimicrobials is to obtain approval by the regulatory agencies for a specific indication. However, the real clinical utility of these trials is limited because the patients included are usually at low risk of infection caused by antibiotic-resistant or difficult-to-treat microorganisms, and the conditions in which the studies are performed differ from those in real life. Therefore, observational studies are an essential complement. Once a new antibiotic has been commercialized, the post-registry follow-up phase begins. The EUCORE registry is a European multicenter, retrospective, non-comparative post-authorization study that included patients receiving at least one dose of daptomycin. Despite their limitations, these types of study provide useful information that should be thoroughly analyzed and interpreted.
authors.affiliation: Unidad Clínica de Enfermedades Infecciosas y Microbiología, Hospital Universitario Virgen Macarena, Sevilla, España. jesusrb@us.es
authors.forename: Jesús
authors.initials: J
authors.lastname: Rodríguez-Baño
mesh_terms: D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy*; D017576:Daptomycin / Q000627:therapeutic use*; D016208:Databases, Factual; D005060:Europe; D006801:Humans; D015337:Multicenter Studies as Topic / Q000379:methods; D011358:Product Surveillance, Postmarketing / Q000379:methods; D012042:Registries; D012189:Retrospective Studies; D015983:Selection Bias; D016896:Treatment Outcome; D035141:Voluntary Programs
chemical_list: D000900:Anti-Bacterial Agents; D017576:Daptomycin