Daptomycin for complicated skin infections

A randomized trial

John Bradley, Chad Glasser, Hernando Patino, Sandra Arnold, Antonio Arrieta, Blaise Congeni, Robert S. Daum, Tsoline Kojaoghlanian, Minjung Yoon, Diane Anastasiou, Dominik J. Wolf, Paula Bokesch

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

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 endof-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.

Original languageEnglish (US)
Article numbere20162477
JournalPediatrics
Volume139
Issue number3
DOIs
StatePublished - Mar 1 2017

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Daptomycin
Standard of Care
Skin
Infection
Safety
Population
Methicillin Resistance
Clindamycin
Vancomycin
Therapeutics
Patient Safety
Methicillin-Resistant Staphylococcus aureus
Creatine Kinase
Signs and Symptoms
Diarrhea
Clinical Trials

All Science Journal Classification (ASJC) codes

  • Pediatrics, Perinatology, and Child Health

Cite this

Bradley, J., Glasser, C., Patino, H., Arnold, S., Arrieta, A., Congeni, B., ... Bokesch, P. (2017). Daptomycin for complicated skin infections: A randomized trial. Pediatrics, 139(3), [e20162477]. https://doi.org/10.1542/peds.2016-2477

Daptomycin for complicated skin infections : A randomized trial. / Bradley, John; Glasser, Chad; Patino, Hernando; Arnold, Sandra; Arrieta, Antonio; Congeni, Blaise; Daum, Robert S.; Kojaoghlanian, Tsoline; Yoon, Minjung; Anastasiou, Diane; Wolf, Dominik J.; Bokesch, Paula.

In: Pediatrics, Vol. 139, No. 3, e20162477, 01.03.2017.

Research output: Contribution to journalArticle

Bradley, J, Glasser, C, Patino, H, Arnold, S, Arrieta, A, Congeni, B, Daum, RS, Kojaoghlanian, T, Yoon, M, Anastasiou, D, Wolf, DJ & Bokesch, P 2017, 'Daptomycin for complicated skin infections: A randomized trial', Pediatrics, vol. 139, no. 3, e20162477. https://doi.org/10.1542/peds.2016-2477
Bradley J, Glasser C, Patino H, Arnold S, Arrieta A, Congeni B et al. Daptomycin for complicated skin infections: A randomized trial. Pediatrics. 2017 Mar 1;139(3). e20162477. https://doi.org/10.1542/peds.2016-2477
Bradley, John ; Glasser, Chad ; Patino, Hernando ; Arnold, Sandra ; Arrieta, Antonio ; Congeni, Blaise ; Daum, Robert S. ; Kojaoghlanian, Tsoline ; Yoon, Minjung ; Anastasiou, Diane ; Wolf, Dominik J. ; Bokesch, Paula. / Daptomycin for complicated skin infections : A randomized trial. In: Pediatrics. 2017 ; Vol. 139, No. 3.
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AU - Bradley, John

AU - Glasser, Chad

AU - Patino, Hernando

AU - Arnold, Sandra

AU - Arrieta, Antonio

AU - Congeni, Blaise

AU - Daum, Robert S.

AU - Kojaoghlanian, Tsoline

AU - Yoon, Minjung

AU - Anastasiou, Diane

AU - Wolf, Dominik J.

AU - Bokesch, Paula

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N2 - 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 endof-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.

AB - 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 endof-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.

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