title: Daptomycin for the treatment of osteomyelitis and orthopaedic device infections: real-world clinical experience from a European registry.
abstract: Osteomyelitis is a serious infection predominantly caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). Orthopaedic device-related infections are complex and require a careful combination of surgical intervention and antimicrobial therapy. Daptomycin, a cyclic lipopeptide, effectively penetrates soft tissue and bone and demonstrates rapid concentration-dependent bactericidal activity against Gram-positive pathogens. This retrospective, non-interventional study evaluated clinical outcomes in patients with osteomyelitis or orthopaedic device infections treated with daptomycin from the European Cubicin® Outcomes Registry and Experience (EU-CORE(SM)) study. Patients were treated between January 2006 and April 2012, with follow-up to 2014. Clinical outcomes were assessed as success (cured or improved), failure or non-evaluable. Of 6,075 patients enrolled, 638 (median age, 63.5 years) had primary infections of osteomyelitis or orthopaedic device infections, 224 had non-prosthetic osteomyelitis, 208 had osteomyelitis related to a permanent or temporary prosthetic device, and 206 had orthopaedic device infections. The most commonly isolated pathogen was S. aureus (214 [49.1 %]; 24.8 % were MRSA). Overall, 455 (71.3 %) patients had received previous antibiotic therapy. Patients underwent surgical interventions, including tissue (225 [35.3 %]) and bone (196 [30.7 %]) debridement, as part of their treatment. Clinical success rates were 82.7 % and 81.7 % in S. aureus and coagulase-negative staphylococcal infections. Adverse events (AEs) and serious AEs assessed as possibly related to daptomycin were observed in 6.7 % and 1.9 % of patients, respectively. Daptomycin was discontinued by 5.5 % of patients due to AEs and 10 (1.6 %) deaths were reported. In conclusion, daptomycin was effective and safe in patients with osteomyelitis or orthopaedic device infections.
authors.affiliation: Orthopaedic Department, School of Medicine, University of Thessalia, Larissa, Greece.
authors.forename: K
authors.initials: K
authors.lastname: Malizos
authors.affiliation: North Tyneside General Hospital, North Shields, UK.
authors.forename: J
authors.initials: J
authors.lastname: Sarma
authors.affiliation: Queen Elizabeth University Hospital, Glasgow, UK.
authors.forename: R A
authors.initials: RA
authors.lastname: Seaton
authors.affiliation: Department of Septic and Reconstructive Surgery, Trauma Center Murnau, Murnau, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Militz
authors.affiliation: Azienda Ospedaliera Universitaria Pisana, Ospedale Cisanello, UO Malattie Infettive, Pisa, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Menichetti
authors.affiliation: Infectious Diseases Hospital Santa Maria della Misericordia Albenga ASL-2, Albenga, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Riccio
authors.affiliation: Center for Orthopaedic and Hand Surgery, University Hospital of Strasbourg, Illkirch, France.
authors.forename: J
authors.initials: J
authors.lastname: Gaudias
authors.affiliation: Novartis Pharmaceuticals AG, Basel, Switzerland.
authors.forename: U
authors.initials: U
authors.lastname: Trostmann
authors.affiliation: Novartis Healthcare Pvt. Ltd., Raheja Mindspace, Hyderabad, India.
authors.forename: R
authors.initials: R
authors.lastname: Pathan
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. kamal.hamed@novartis.com.
authors.forename: K
authors.identifier: http://orcid.org/0000-0003-1896-9736
authors.initials: K
authors.lastname: Hamed
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D001419:Bacteria / Q000145:classification / Q000302:isolation & purification; D002648:Child; D017576:Daptomycin / Q000627:therapeutic use*; D003646:Debridement; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010019:Osteomyelitis / Q000188:drug therapy* / Q000382:microbiology / Q000601:surgery; D016459:Prosthesis-Related Infections / Q000188:drug therapy* / Q000382:microbiology / Q000601:surgery; D012189:Retrospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D017576:Daptomycin