Findings from a first-of-its-kind clinical trial suggest that intravenous daptomycin may be effective and well-tolerated in children, possibly providing an alternative treatment against methicillin-resistant Staphylococcus aureus (MRSA) skin infections in this patient population.
Daptomycin is active against MRSA and is currently only approved for adult use in treating skin and skin structure infections, and bloodstream infections.
“The safety and efficacy of intravenous daptomycin was comparable to standard-of-care IV antibiotics used for hospitalized children, usually vancomycin or clindamycin for MRSA and cefazolin for methicillin-susceptible strains of S. aureus,” said lead author, John Bradley, MD.
The study was randomized and investigator-blinded, and included 257 children aged 1 to 17 years who were exposed to daptomycin, and 132 children treated with standard of care (SOC; primarily clindamycin or vancomycin). All patients had complicated skin and skin structure infections (cSSSI), with 35% having confirmed methicillin-resistant Staphylococcus aureus.
Results showed that daptomycin had similar safety to the SOC, with the proportions of safety population patients with treatment-related adverse events similar between the daptomycin (14%) and SOC (17%) group. Incidence of diarrhea was 7% and 5% for daptomycin and SOC; and increases in creatine phosphokinase were 6% and 5%, respectively.
Clinical success rate — defined by blinded evaluator-assessed complete/partial resolution of cSSSI symptoms 7–14 days after treatment — in the intent to treat population were also similar for the daptomycin (91%) and SOC group.
Dosing strategies were initially based on adult experiences but were then changed when the researchers found that the younger the child, the more quickly their bodies eliminated daptomycin.
The Food and Drug Administration is currently reviewing whether to approve daptomycin use in children.
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