Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease
The purpose of this study is to:
- Study the pharmacokinetics and safety of daptomycin in children on hemodialysis (HD) and peritoneal dialysis (PD).
- Determine urine, HD and PD clearance of daptomycin.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease|
- To evaluate the pharmacokinetic profiles of a single 5 mg/kg dose of daptomycin IV in children who are on hemodialysis or peritoneal dialysis [ Time Frame: serial blood drug concentrations collected over the course of 3 days ] [ Designated as safety issue: No ]
- To determine urine, HD and PD clearance of daptomycin [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
|Study Start Date:||November 2009|
|Study Completion Date:||April 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Daptomycin IV 5 mg/kg one time dose
Other Name: Cubicin
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01012089
|United States, Oklahoma|
|The Children's Hospital at the University of Oklahoma Medical Center|
|Oklahoma City, Oklahoma, United States, 73013|
|Principal Investigator:||Teresa V Lewis, Pharm.D.||University of Oklahoma|
|Principal Investigator:||Martin A Turman, M.D., Ph.D.||University of Oklahoma|