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Ceftaroline fosamil safe, effective for children with ABSSSIs
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Treatment with intravenous ceftaroline fosamil, with optional conversion to oral medication, was as effective and well-tolerated as comparator therapy in children with acute bacterial skin and skin structure infections, according to recent research.
“Acute bacterial skin and skin structure infections (ABSSSIs) are a common and increasing cause of hospitalization in pediatric patients and can result in serious complications if not adequately treated,” Bartosz Korczowski, MD, PhD, of the University of Rzeszów in Poland, and colleagues wrote. “Ceftaroline fosamil was found to be safe and effective in adults with either ABSSSIs or community-acquired bacterial pneumonia. This is the first study to investigate the safety and tolerability of ceftaroline fosamil in children with ABSSSI.”
The observer-blinded study, conducted from August 2012 to May 2014 within multiple centers, comprised 163 children with ABSSSIs aged 2 months to 17 years. Of those, 159 patients were given treatment. Participants were randomly divided 2:1 into treatment groups and assigned IV ceftaroline fosamil or IV comparator — vancomycin or cefazolin, plus optional aztreonam. After day 4, the participants were given the option to switch to oral antibacterials.
Researchers found similar rates of drug-related treatment-emergent adverse events in both treatment groups (ceftaroline fosamil, 22% [23/106]; comparator, 23% [12/53]). In the ceftaroline fosamil group, researchers observed one incidence of severe hypersensitivity correlated to the IV drug. Early clinical response, defined as the reduction of 20% or more of the infection from the baseline, was achieved in 85% of the adjusted intent-to-treat population in both study drug groups (ceftaroline fosamil, 91/107; comparator, 44/52).
Data showed high clinical cure rates at test-of-cure in patients receiving ceftaroline fosamil (94% [101/107]) and comparator (87% [45/52]). More patients with MRSA in the ceftaroline fosamil group than the comparator group attained a satisfactory microbiologic response following 8 to 15 days after the final dose of an IV or oral antibiotic (89% [16/18] vs. 57% [4/7], respectively).
“These study data support ceftaroline fosamil as having a favorable safety profile when used for the treatment of pediatric patients with ABSSSIs,” the researchers concluded. – by Alaina Tedesco
Disclosure: The researchers report no relevant financial disclosures.
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