title: Effectiveness and safety of daptomycin in complicated skin and soft-tissue infections and bacteraemia in clinical practice: results of a large non-interventional study.
abstract: This retrospective analysis of patients from eight countries included in the European Cubicin(®) Outcomes Registry and Experience (EU-CORE(SM)) captures the first post-approval years of clinical experience with daptomycin in its licensed indications. Of the total 1127 patients enrolled in EU-CORE between 2006 and 2008, 373 had a primary complicated skin and soft-tissue infection (cSSTI), most commonly surgical-site infection (48%), and 244 had bacteraemia, 55% of which were catheter-related. The most common pathogens were Staphylococcus aureus in cSSTIs (43%) and coagulase-negative staphylococci in bacteraemia (36%). The most frequently prescribed daptomycin doses were 4 mg/kg and 6 mg/kg for cSSTIs, and 6 mg/kg for bacteraemia. The median duration of inpatient and outpatient treatment, respectively, was 13 days and 8 days for cSSTIs and 8 days and 10 days for bacteraemia. Clinical success was reported for 81% of patients with cSSTIs and 77% with bacteraemia, with 82% success overall for infections caused by S. aureus. A trend towards higher clinical success was noted with higher daptomycin doses in bacteraemia (78% for 6 mg/kg vs. 90% for doses >6 mg/kg). Daptomycin demonstrated a favourable safety profile. Adverse events regardless of relationship to study drug were reported for 11% of patients with cSSTIs and 24% with bacteraemia, most commonly septic shock [7 patients (2%) with cSSTIs and 5 patients (2%) with bacteraemia]. These results demonstrate that daptomycin is effective and well tolerated in the treatment of cSSTIs and bacteraemia caused by Gram-positive bacteria in clinical practice.
authors.affiliation: Darent Valley Hospital, Dartford and Gravesham NHS Trust, Kent, UK. armando.gonzalez@dvh.nhs.uk
authors.forename: Armando
authors.initials: A
authors.lastname: Gonzalez-Ruiz
authors.forename: Andres
authors.initials: A
authors.lastname: Beiras-Fernandez
authors.forename: Hans
authors.initials: H
authors.lastname: Lehmkuhl
authors.forename: Pascal M
authors.initials: PM
authors.lastname: Dohmen
authors.forename: Juergen
authors.initials: J
authors.lastname: Loeffler
authors.forename: Ricardo L
authors.initials: RL
authors.lastname: Chaves
mesh_terms: D000328:Adult; D000900:Anti-Bacterial Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D016470:Bacteremia / Q000188:drug therapy* / Q000382:microbiology; D017576:Daptomycin / Q000009:adverse effects* / Q000627:therapeutic use*; D005060:Europe; D005260:Female; D006095:Gram-Positive Cocci / Q000187:drug effects; D006801:Humans; D008297:Male; D010818:Practice Patterns, Physicians'; D012042:Registries; D012189:Retrospective Studies; D017192:Skin Diseases, Bacterial / Q000188:drug therapy* / Q000382:microbiology; D018461:Soft Tissue Infections / Q000188:drug therapy* / Q000382:microbiology; D013530:Surgical Wound Infection / Q000188:drug therapy / Q000382:microbiology; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D017576:Daptomycin