Background: Community-acquired bacterial pneumonia (CABP) remains a major infection among children, despite the use of pneumococcal vaccination. Ceftaroline fosamil is a broad-spectrum cephalosporin antibiotic with activity against many bacteria, including Streptococcus pneumoniae (both penicillin-nonsusceptible and multidrug-resistant strains) and Staphylococcus aureus (including methicillin-resistant S. aureus). This article describes the safety, tolerability, and effectiveness of ceftaroline fosamil in the treatment of pediatric patients hospitalized with CABP, from a randomized, active-controlled, observer-blinded clinical study (registration number NCT01530763).
Methods: Pediatric patients were stratified into 4 age cohorts and randomized (3:1) to receive either intravenous ceftaroline fosamil or ceftriaxone, with optional oral switch for a total treatment duration of 5–14 days. Enrollment was planned for 160 patients. Data collected included demographics, infection characteristics and pathogens. Treatment-emergent adverse events, clinical outcomes, and microbiologic responses were assessed.
Results: Ceftaroline fosamil was well tolerated. Similar percentages of patients in the ceftaroline fosamil (55/121; 45%) and ceftriaxone (18/39; 46%) groups reported treatment-emergent adverse events. Coombs seroconversion was observed in 17% of patients in the ceftaroline fosamil group; however, no evidence of hemolytic anemia or hemolysis was found. No deaths were reported during the study. Ceftaroline fosamil had similar effectiveness to ceftriaxone, with high clinical cure rates at test-of-cure in the modified intent-to-treat population (94/107; 88% and 32/36; 89%, respectively). Three documented S. aureus infections were successfully treated in the ceftaroline group, including one caused by methicillin-resistant S. aureus.
Conclusions: The results of this study suggest that ceftaroline fosamil may be an important treatment option for pediatric patients hospitalized with CABP.
From the *Division of Infectious Diseases, Department of Pediatrics, University of California at San Diego and Rady Children’s Hospital, San Diego, California; †Faculty of Medicine, 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary; ‡Medical College, University of Rzeszow, Rzeszow, Poland; §Department of Clinical Development, Cerexa, Inc., Oakland, California; and; ¶Section of Pediatric Infectious Diseases, Department of Pediatrics, Baylor College of Medicine and Texas Children’s Hospital, Feigin Center, Houston, Texas.
Accepted for publication November 23, 2015.
This study was funded by Cerexa, Inc. a wholly owned subsidiary of Forest Laboratories, which was acquired by Actavis PLC, an Allergan affiliate, in July 2014. Editorial and writing assistance was provided by Micron Research Ltd, Ely, UK, and funded by Forest Laboratories.
C.R.C., A.N., B.K., J.S.B., and S.L.K. are study investigators for this ceftaroline fosamil study. The employer of C.R.C. and J.S.B., the University of California, San Diego, has contracts with Cerexa/Forest for both consulting and clinical investigation. T.O., A.J. and H.D.F. are former employees of Cerexa, Inc. and they have received stock and stock options from Forest Laboratories. As a result of the acquisition, T.O., A.J. and H.D.F. are shareholders of Actavis plc. A.J. and H.D.F. are also consultants for Actavis plc.
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