Daptomycin for Complicated Skin Infections: A Randomized Trial.

Autor:	Bradley J; Division of Infectious Diseases, Department of Pediatrics, University of California San Diego, San Diego, California; jbradley@rchsd.org.; Rady Children's Hospital, San Diego, California., Glasser C; Merck & Co, Inc, Kenilworth, New Jersey., Patino H; Merck & Co, Inc, Kenilworth, New Jersey., Arnold SR; University of Tennessee Health Science Center, Le Bonheur Children's Hospital, Memphis, Tennessee., Arrieta A; Children's Hospital of Orange County, Orange, California., Congeni B; Akron Children's Hospital, Akron, Ohio., Daum RS; MRSA Research Center, Department of Pediatrics, University of Chicago, Chicago, Illinois; and., Kojaoghlanian T; Children's Hospital at Montefiore, Bronx, New York., Yoon M; Merck & Co, Inc, Kenilworth, New Jersey., Anastasiou D; Merck & Co, Inc, Kenilworth, New Jersey., Wolf DJ; Merck & Co, Inc, Kenilworth, New Jersey., Bokesch P; Merck & Co, Inc, Kenilworth, New Jersey.
Jazyk:	angličtina
Zdroj:	Pediatrics [Pediatrics] 2017 Mar; Vol. 139 (3). Date of Electronic Publication: 2017 Feb 15.
DOI:	10.1542/peds.2016-2477
Abstrakt:	Background: Complicated skin and skin structure infections (cSSSI) are common in children. Due to safety and resistance issues with recommended agents, new treatment options would be advantageous. Methods: Multicenter, evaluator-blinded clinical trial. Patients 1 to 17 years old with cSSSI caused by Gram-positive pathogens were randomized 2:1 to intravenous daptomycin or standard-of-care (SOC) treatment for ≤14 days. Daptomycin was administered once daily with dosing by patient age: 12 to 17 years, 5 mg/kg; 7 to 11 years, 7 mg/kg; 2 to 6 years, 9 mg/kg; 12 to 23 months, 10 mg/kg. The primary objective was to evaluate daptomycin safety. The secondary objective was to assess the efficacy of daptomycin compared with SOC. The intent-to-treat (ITT) population consisted of all randomized patients with any dose of study drug. Results: The ITT population comprised 257 daptomycin and 132 SOC patients (primarily clindamycin or vancomycin); 35% had confirmed methicillin-resistant Staphylococcus aureus . The most common adverse events were diarrhea (7% daptomycin, 5% SOC) and increased creatine phosphokinase (6% daptomycin, 5% SOC). The proportions of safety population patients with treatment-related adverse events were similar between the daptomycin (14%) and SOC (17%) groups. Clinical success rates (blinded evaluator-assessed complete/partial resolution of cSSSI signs and symptoms 7-14 days after end-of-treatment) in the ITT population were also similar for the daptomycin (91%) and SOC groups. Conclusions: Once-daily daptomycin was well tolerated, with safety and efficacy comparable to SOC in children/adolescents with cSSSI caused by Gram-positive pathogens, including community-acquired methicillin-resistant S aureus . (Copyright © 2017 by the American Academy of Pediatrics.)
Databáze:	MEDLINE
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