Bacteremia Clinical Trial
Official title:
A Comparative Evaluation of the Safety and Efficacy of Daptomycin Versus Standard of Care in Pediatric Subjects One - Seventeen Years of Age With Bacteremia Caused by Staphylococcus Aureus.
The intent of this study is to describe the safety and efficacy of daptomycin versus standard of care (SOC) in pediatric participants aged 1-17 years with bacteremia caused by Staphylococcus aureus (S. aureus).
S. aureus causes a series of invasive diseases in adults and children, including bacteremia.
Infections due to S. aureus in children, particularly those due to methicillin resistant S.
aureus (MRSA), are a growing world-wide public health concern.
Daptomycin, a cyclic lipopeptide antibacterial agent, shows rapid in vitro bactericidal
activity with concentration-dependent killing for Gram-positive organisms, including S.
aureus. Surveillance studies have demonstrated a daptomycin MIC90 of 0.5µg/ml for both
methicillin-susceptible S. aureus (MSSA) and MRSA with >99% of MRSA isolates being
categorized as susceptible by the Food and Drug Administration (FDA), European Committee of
antimicrobial susceptibility testing (EUCAST) and Clinical and Laboratory Standards Institute
(CLSI) breakpoints (5). Clinical trials in adults demonstrated that daptomycin was safe and
efficacious in complicated skin and skin structure infections (cSSSI) and bloodstream
infections caused by S. aureus, including right-sided infective endocarditis (RIE). However,
information on the safety and efficacy of daptomycin for use in children is lacking.
The intent of this study in children is to confirm the safety of daptomycin at mean steady
state systemic exposures (AUC) similar to those reported for adults treated at 6 mg/kg for
bacteremia.
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