Abstract

BackgroundOsteomyelitis is often challenging to treat. This analysis examined the clinical experience of patients with gram-positive osteomyelitis treated with ceftaroline fosamil in the phase 4 Clinical Assessment Program and Teflaro® Utilization Registry (CAPTURE) study.MethodsData including patient demographics, past illnesses, risk factors, disease characteristics, antibiotic use, pathogens isolated, and clinical outcome were collected between September 2013 and February 2015 by review of randomly ordered patient charts from participating sites in the United States. Clinical success was defined as discontinuation of ceftaroline fosamil following clinical cure with no further need for antibiotics or clinical improvement with switch to another antibiotic treatment.ResultsA total of 150 patients with gram-positive osteomyelitis were treated with ceftaroline fosamil. Most patients (117/150; 78.0%) were treated with 600 mg ceftaroline fosamil per dose; 143/150 patients (95.3%) received a dose every 12 h. The majority (89/150 patients; 59.3%) had been previously diagnosed with diabetes mellitus or peripheral arterial disease. Osteomyelitis was associated with hardware in 32/150 patients (21.3%). Methicillin-resistant and methicillin-susceptible Staphylococcus aureus (MRSA; MSSA) were the most commonly isolated pathogens, observed in 93/150 (62.0%) and 21/150 (14.0%) patients, respectively. Clinical success with ceftaroline fosamil therapy was observed in 139/150 (92.7%) patients overall, 81/89 (91.0%) patients with diabetes or peripheral arterial disease, and 18/20 (90.0%) patients who had hardware implanted before ceftaroline fosamil therapy (none had hardware removed during therapy). Patients who received prior antibiotic therapy or ceftaroline fosamil as monotherapy experienced clinical success rates of 93.9% (107/114) and 91% (91/100), respectively. Among patients who received concurrent antibiotic therapy, the clinical success rate was 96.0% (48/50). Patients who were infected with MRSA or MSSA had clinical success rates of 92.5% (86/93) and 100% (21/21), respectively. A total of 2/150 (1.3%) patients discontinued ceftaroline fosamil therapy because of adverse events.ConclusionsClinical success rates with ceftaroline fosamil were high in patients with gram-positive osteomyelitis, including those with diabetes or peripheral arterial disease and those with MRSA or MSSA.

Highlights

  • This study was conducted in compliance with the International Conference on Harmonisation (ICH) Technical Requirements for Registration of Pharmaceuticals for Human Use: Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance (1996), Good Pharmacoepidemiology Practice, Health Insurance Portability and Accountability Act, 21 CFR Part 11, and any additional national or institutional review boards (IRBs) requirements

  • Patients with gram-positive osteomyelitis enrolled in the Clinical Assessment Program and Teflaro® Utilization Registry (CAPTURE) study exhibited a range of characteristics that are representative of patients commonly treated for osteomyelitis in the clinic, including advanced age, high body mass, past illnesses that include diabetes mellitus (DM) and/or peripheral arterial disease (PAD), and infection with methicillin-resistant S aureus (MRSA)

  • Data from this study provide information regarding the use of ceftaroline fosamil in clinical practice for treatment of osteomyelitis

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Summary

Introduction

The annual incidence of osteomyelitis is estimated to be approximately 22 cases per 100,000 person-years, with the rate increasing with age [1]. Acute osteomyelitis is characterized by bone alterations caused by pathogenic bacteria occurring within approximately 2 weeks of infection onset, whereas chronic osteomyelitis may be characterized by. 20% of patients with diabetic foot infection have underlying osteomyelitis and are at risk for lower extremity amputation [6, 7]. Peripheral neuropathy and peripheral arterial disease (PAD) contribute to the increased risk of osteomyelitis in patients with diabetes mellitus (DM) by causing infections to go unnoticed and impeding the healing process, respectively [2]

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