Annals of Long Term Care

Infectious Diseases Society of America 47th Annual Meeting
October 29-November 1, 2009; Philadelphia, PA

POSTER

Clinical Experience with Daptomycin for the Treatment of Patients with Bacteremic Skin and Skin-Structure Infections

Philadelphia, PA—Data from the Cubicin® Outcomes Registry and Experience (CORE) 2005-2008, a retrospective, multicenter, observational chart review to assess characteristics and clinical outcome of patients receiving daptomycin, support the use of daptomycin for skin and skin structure infections (SSSI) bacteremia (BSI). Researchers concluded that further study is warranted to characterize high-risk patients for BSI associated with SSSI and to evaluate treatment outcomes.

Findings of the study were presented at the annual IDSA meeting. All patients with SSSI BSI in CORE 2005-2008 were studied, and primary outcome (success, failure, nonevaluable) was investigator-assessed at the end of daptomycin therapy; a secondary outcome was sponsor-assessed where daptomycin discontinued due to adverse event (AE), death (any cause), and/or evidence for lack of clinical response were evaluated as failures. Demographics and efficacy were based on investigator-evaluable population; all patients were included for safety. A standardized case report form and protocol were used to collect demographic, microbiologic, and clinical information on patients who had been treated with daptomycin from 62 separate institutions in the United States from January 2005 through December 2008. After institutional review board approval, clinical information was collected from medical records by trained study investigators. The methods have been previously published (Rolston et al, Am J Med 2007).

Adult patients (≥ 18 yr) with an investigator-defined diagnosis of both bacteremia and an uncomplicated or complicated skin and soft tissue infection were evaluated for inclusion. Specific diagnoses included were complicated SSSI and uncomplicated SSSI. Catheter-related bacteremia was excluded for evaluation. Patients were considered evaluable for efficacy if the response to daptomycin as assessed by the investigator was classified as one of the following: cure; improved; or failure. Nonevaluable patients were excluded from the primary efficacy analysis; however, they were included in the safety analysis. No pre-specified duration of therapy was required for efficacy evaluation.

Results were as follows: 111/2269 (5%) patients with SSSI had concomitant BSI. Eighty-eight out of 111 (79%) patients were evaluable for the primary outcome; 28 of 88 (32%) were > 65 years; 36 of 88 (41%) were diabetic, and 8 of 88 (9%) had peripheral vascular disease. Fifty-six of 88 (64%) had complicated SSSI and 32 of 88 (36%) uncomplicated SSSI; 17 of 88 (19%) had creatinine clearance (CrCl) < 30 ml/min. Seventy-five percent of patients had Staphylococcus sp, 48% of which was methicillin-resistant Staphylococcus aureus (MRSA), 30% had Enterococcus sp (62% of which was vancomycin-resistant enterococci [VRE]). Daptomycin median (min, max) initial dose was 5.5 mg/kg (3.7, 10.0; 42% ≥ 6 mg/kg); length of therapy was 10.5 days (interquartile range 6-21). Eighty-one percent of patients received prior antibiotics: 56% vancomycin; 14% linezolid. The primary outcome of success was 89% (78/88) overall and was 94% (30/32) in patients with MRSA, 63% (10/16) in patients with VRE. Success in patients with a single pathogen was 91% (42/46) and 86% (36/42) in polymicrobial infections. Success was 94% versus 87% when used as first-line therapy versus secondary therapy. No differences in outcomes were observed when assessed by CrCl < 30; abscess or neutropenia. Sponsor-assessed outcome in 93 patients revealed an 80% success rate. Eight out of 111 patients (7%) had 10 AEs possibly related to daptomycin; three were serious.