Clinical experience with daptomycin in Europe
Abstract number: P766
Gonzalez-Ruiz A., Daugelat S., Beiras-Fernandez A., Lehmkuhl H., Gargalianos-Kakolyris P., Dailiana Z., Galloway A., González Ramallo V.J., Dohmen P., Skoutelis A., Seaton R.A., Almirante B., Dogan G., Thurston H.J., Chaves R.
Objective: To describe the clinical experience with daptomycin (DAP) in Europe since marketing authorisation in January 2006.
Methods: The European Cubicin® Outcomes Registry and Experience (EU-CORESM) is a retrospective, non-interventional records review evaluating outcomes of patients (pts) receiving DAP. Investigators collected demographic, antibiotic, microbiological and clinical data from Jan 2006 to Sep 2008 from 118 institutions in nine European countries. Pts with multiple infection types were categorised by severity of infection (in order of decreasing severity: endocarditis, osteomyelitis, bacteraemia, other [foreign body, septic arthritis, pyelonephritis/UTI, necrotising fasciitis], complicated skin and soft tissue infection [cSSTI], uncomplicated skin and soft tissue infection [uSSTI]). Outcomes were assessed by investigators using standard definitions.
Results: A total of 1127 pts were enrolled in EU-CORESM in the data reporting period. Of the pts in the safety population (n = 1127), 64% were male, 46% were aged 65 years, 14% had CrCl <30 ml/min and 9% were on dialysis at the initiation of DAP therapy; 77% of pts were hospitalised prior to DAP therapy. The majority (89%) had significant underlying disease, including hypertension (30%), diabetes mellitus (26%) and chronic renal failure (13%). Primary infections included cSSTI (33%), bacteraemia (22%), endocarditis (12%), uSSTI (11%), foreign body/prosthesis (8%) and osteomyelitis (6%). Clinical outcomes were success, defined as 'cure plus improved' (79%), failure (8%) and non-evaluable (13%). DAP was used as second-line therapy in 70% of pts, most frequently following therapy with glycopeptides (28%). DAP was given empirically in 53% of pts and methicillin-resistant Staphylococcus aureus infection was suspected in 29% of pts. Cultures were obtained in 91% of pts: the most frequently isolated pathogen was S. aureus of which 52% had confirmed methicillin resistance. The initial dose of DAP was 6 mg/kg in most pts (47%), whereas 32% of pts received 4 mg/kg and 20% received other doses. Outpatient DAP therapy was received by 14% of pts, whereas the majority were treated in hospital, where DAP was used with concomitant antibiotics in 67% of pts.
Conclusions: DAP was used to treat a range of infections, most frequently cSSTIs, with a large proportion of pts aged 65 years and with significant comorbidities. DAP was frequently used as second-line therapy, achieving an overall success rate of 79%.
|Session name:||19th European Congress of Clinical Microbiology and Infectious Diseases|
|Location:||Helsinki, Finland, 16 - 19 May 2009|
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