Methods: In a randomized, multicenter, open-label study, patients were assigned 2:1 to intravenous DAP or SOC (vancomycin, semi-synthetic penicillin, 1st-generation cephalosporin, or clindamycin). DAP dose varied by age with the goal of achieving exposures similar to adults: ages 1–6 years, 12 mg/kg once daily (QD); 7–11 years, 9 mg/kg QD; 12–17 years, 7 mg/kg QD. The primary endpoint was safety (incidence of adverse events [AEs]). Secondary endpoints were favorable clinical response (cure/improvement) at the test of cure (TOC) visit and overall therapeutic success (combined favorable clinical and microbiological response) at TOC, based on blinded evaluator assessments. The study was not powered to detect statistical differences between arms.
Results: Overall, 81 patients with bacteremia (73 [90.1%] with S. aureus; 8 [9.9%] with coagulase-negative Staphylococcus [CoNS]/other) were randomized and treated (Table). Rates of treatment-related AEs (TRAEs) were similar between arms. There were no severe or serious TRAEs including deaths. At TOC, 45/51 (88.2%) evaluable DAP and 17/22 (77.3%) SOC patients had favorable clinical response, and 37/51 (72.5%) DAP and 13/22 (59.1%) SOC patients had overall success.
Conclusion: DAP was generally safe and well tolerated and was as effective as SOC in the treatment of S. aureus bacteremia in pediatric patients.
M. W. Popejoy, Merck: Employee , Salary
M. Bensaci, Merck: Employee , Salary
A. Grandhi, Merck: Employee , Salary
N. Kartsonis, Merck: Employee , Salary