Chronic Kidney Disease Clinical Trial
Official title:
Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease
The purpose of this study is to:
1. Study the pharmacokinetics and safety of daptomycin in children on hemodialysis (HD) and
peritoneal dialysis (PD).
2. Determine urine, HD and PD clearance of daptomycin.
Infectious and sepsis events are one of the most common complications in children with
chronic kidney disease. The incidence is highest in children with an access for dialysis,
especially in those with catheters. Staphylococcal species account for more than 50% of
access infections (ranging from 58-77%). Failure to clear the infection results in loss of
dialysis access.
Daptomycin is a new antibiotic that provides coverage against most gram positive bacteria
including methicillin-resistant staphylococci, vancomycin-intermediate Staphylococcus aureus,
and vancomycin-resistant enterococci. The pharmacokinetics of daptomycin in children on
dialysis, a group of patients who may need the medication the most, remains unknown.
Children on HD or PD with suspected or confirmed infections due to gram-positive bacteria and
who are concurrently treated with standard of care antibiotics will be considered for this
study. Each patient will be given a onetime dose of Cubicin (daptomycin). After receiving
daptomycin, serial blood samples along with dialysis effluent and urine (obtained from
non-anuric patients) will be collected to evaluate the pharmacokinetic profile of the drug.
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