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Abstract
Objectives: Ceftaroline fosamil is a novel cephalosporin with bactericidal activity against common pathogens associated with hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP). Ceftaroline is inactive against extended-spectrum β-lactamase-producing or AmpC-overexpressing Enterobacteriaceae and has limited activity against Pseudomonas aeruginosa. CAPTURE is a multicenter, retrospective study designed to collect information on contemporary clinical use of ceftaroline fosamil in the USA. Data on off-label use of ceftaroline fosamil for the treatment of patients with HAP/VAP between September 2013 and March 2014 are presented. Methods: Data were collected at participating study centers by randomized selection and review of patients’ charts, and included patients’ demographics, disease characteristics, pathogens isolated, antibiotic treatment and clinical outcomes. Patients receiving at least four consecutive doses of ceftaroline fosamil, with data available for determination of clinical cure, comprised the evaluable population. Clinical success was defined as either clinical cure with no further need for antibiotics treatment, or clinical improvement with a switch to another antibiotic. Results: A total of 40 patients were evaluated: 27 with HAP and 13 with VAP. Demographics for patients with HAP and VAP were similar (59% male, mean age of 63 years and 54% male, mean age of 58 years, respectively). The clinical success rates were 75% overall, 82% in patients with HAP and 62% in patients with VAP. Clinical success rates for patients with methicillin-resistant Staphylococcus aureus (MRSA) isolated were 58% in patients with HAP and 57% in patients with VAP. Ceftaroline fosamil was used as a second-line therapy in majority of patients (85%) with clinical success rates of 79% similar to the published literature. Conclusion: The CAPTURE study data support further evaluation of ceftaroline fosamil as an effective treatment option for HAP and VAP when a ceftaroline susceptible etiologic pathogen is identified, including MRSA, or as a concurrent therapy when resistant Gram-negative pathogens are suspected.
Acknowledgements
We thank the participating sites, investigators and their staff for their contribution to this study.
Declaration of interest
Writing and editorial services for this manuscript were provided by Micron Research Limited and funded by Actavis plc. KS Kaye and G Udeani are study investigators for CAPTURE, the ceftaroline fosamil study funded by Cerexa, Inc., a wholly owned subsidiary of Forest Laboratories. KS Kaye and G Udeani are also consultants for Cerexa, Inc., a wholly owned subsidiary of Forest Laboratories. Actavis acquired Forest Laboratories in July 2014. P Cole and HD Friedland are former employees of Cerexa, Inc., a wholly owned subsidiary of Forest Laboratories, and have received stock and stock options from Forest Laboratories. Actavis acquired Forest Laboratories in July 2014. As a result of the acquisition, P Cole and HD Friedland are shareholders of Actavis plc. HD Friedland is also a consultant for Actavis plc. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.