Early Use of Ceftaroline Fosamil in the United States Veterans Health Care System

Abstract

Background Ceftaroline fosamil is U.S. FDA-approved for acute bacterial skin and skin structure infections and community acquired bacterial pneumonia, but it is unknown how ceftaroline is being used in real-world settings or how adverse effects (AEs) and mortality compare to clinical trials. Objective This study describes ceftaroline use, AEs, and mortality in U.S. Veterans Health Administration (VHA) hospital patients. Methods This phase 4, population-based, epidemiologic study analyzed patients ≥18 years old who received ≥1 ceftaroline dose within 14 days of admission at 69 VHA hospitals in 41 U.S. states/territories from 10/1/10–9/30/14. VHA repository data were linked using unique patient identifiers. Diagnoses and AEs were determined using ICD9-CM and CSS codes. Demographics, AEs within 30 days of therapy initiation, and all-cause in-hospital mortality were summarized using descriptive statistics. Results 764 patients met study criteria. Patients were 97% male and 56% white, with a median age of 61 years and a Charlson score of 6. Diagnoses included skin (40%), sepsis (30%), osteomyelitis (25%), diabetic foot (22%), pneumonia (16%), bacteremia (11%), endocarditis (6%), meningitis (2%), and device (2%) infections. Ceftaroline was used first-line (37%), second-line (56%), and third-line or greater (7%). Patients received ceftaroline a median of 3 days after hospital admission. All-cause in-hospital mortality rates were: overall (5%), skin (2%), sepsis (9%), osteomyelitis (3%), diabetic foot (1%), pneumonia (13%), bacteremia (6%), endocarditis (11%), meningitis (6%), and device (13%). Eosinophilia, leukopenia, leukocytosis, fibromyalgia, myalgia and myositis, and polymyalgia rates were <1% each. Conclusions Ceftaroline is used in VHA hospitals for various diagnoses. Mortality was low and comparable with rates from clinical trials. Additional studies comparing ceftaroline to other drugs used in similar situations are needed.

Off-label use of ceftaroline fosamil: A systematic review

“…Eleven published studies [6], [9], [10], [11], [12], [13], [14], [15], [16], [17], [18] were found in the literature reporting the successful use of ceftaroline in MRSA bacteremia. 2 matched case-control, 5…”

Ceftaroline-Associated Neutropenia: Case Series and Literature Review of Incidence, Risk Factors, and Outcomes

“…For instance, Staphylococcus aureus remains a leading cause of bacteremia and endocarditis, with an increasing preponderance due to methicillin-resistant S. aureus (MRSA) strains [1, 2]. Given the limitations of the currently available antibiotics (eg, vancomycin) for treating MRSA infections, including drug intolerance, adverse events, and/or clinical failure [3, 4], new antibiotics with anti-MRSA activity have been recently developed.…”

“…Postmarketing data are important for detecting unexpected adverse events associated with newly marketed drugs, especially when they are utilized for “off-label” use, an increasingly common practice for multidrug-resistant organism (MDRO) infections with limited treatment options. As such, ceftaroline has been utilized to treat MRSA bacteremia, endocarditis, and orthopedic infections [3, 10]. For these indications, ceftaroline has often been utilized for longer treatment durations (up to ≥6 weeks).…”

New Antibiotics in the Therapy of Osteomyelitis

“…In a rabbit osteomyelitis model with MRSA it was superior to vancomycin [66] . Data for human osteomyelitis are numerous but anecdotal [67] . In these few reports and a recent review of roughly 180 osteomyelitis cases in the USA [67] , ceftaroline reveals similar success rates to comparator drugs [67][68][69] , but studies are clearly needed [69] .…”