Open-Label Randomized Trial of Early Clinical Outcomes of Ceftaroline Fosamil Versus Vancomycin for the Treatment of Acute Bacterial Skin and Skin Structure Infections at Risk of Methicillin-Resistant Staphylococcus aureus

Autor: Kate Reyes, Robert Welch, Ryan P. Mynatt, Susan L. Davis, Evan J. Zasowski, Jason M. Pogue, Suprat S. Wilson, Christopher Giuliano, Robert Sherwin, Wasif Hafeez, Kyle P. Murray, Keith S Kaye, Pamela Hartman, Anthony M. Casapao, Kimberly C. Claeys, Crystal Arthur, Colleen Rieck, Leonard B. Johnson, George Delgado, Michael J. Rybak, Nitin N. Bhatia, James Gordon, Trang D Trinh, Robert Takla, Donald P. Levine
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Zdroj: Infectious Diseases and Therapy, Vol 8, Iss 2, Pp 199-208 (2019)
Infectious Diseases and Therapy
ISSN: 2193-6382
2193-8229
Popis: Introduction Acute bacterial skin and skin structure infections (ABSSSIs) remain among the most common infectious processes seen in the clinical setting. For patients with complicated ABSSSIs deemed to require intravenous antibiotics, vancomycin remains the mainstay therapy. Ceftaroline has been shown to be non-inferior to vancomycin and may result in faster resolution of signs of infection. Methods Multicenter, prospective, open-label, randomized trial of ceftaroline versus vancomycin for the treatment of adult patients admitted for management of ABSSSIs from April 2012 to May 2016; 166 patients in the clinically evaluable (CE) group were needed to determine a 20% difference in primary outcome of clinical response at day 2 or 3 of antibiotics. Clinical response was defined as cessation of spread of lesion and improvement in systemic signs/symptoms of infection. A secondary outcome was a ≥ 20% reduction in lesion size at day 2 or 3 of antibiotics. Results One hundred seventy-four patients were enrolled in the intention-to-treat (ITT) group and 108 were CE. Among CE patients, 54 were randomized to ceftaroline and 54 to vancomycin. Baseline characteristics were similar except patients in the ceftaroline arm were older and had a non-significantly higher degree of comorbidities (median Charlson score 2 vs. 4, respectively). Cellulitis was the most common type of ABSSSI (85.2% vs. 79.6%, respectively). Rapid diagnostic testing of available cultures (n = 55) demonstrated high agreement with clinical microbiology for identification of Staphylococcus aureus (100%) and MRSA (100%). There was no significant difference in primary outcome of day 2 or 3 clinical response (50.0% vs. 51.9%). Conclusion Early clinical response between vancomycin- and ceftaroline-treated ABSSSIs was similar. Patients with ABSSSIs rarely remained hospitalized for > 2–3 days, thus limiting our ability to critically assess clinical outcomes. Trial Registration ClinicalTrials.gov identifier, NCT02582203. Funding Allergan plc.
Databáze: OpenAIRE
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