[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.