Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease
|ClinicalTrials.gov Identifier: NCT01012089|
Recruitment Status : Completed
First Posted : November 11, 2009
Results First Posted : June 5, 2018
Last Update Posted : June 5, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease Bacterial Infection||Drug: Daptomycin||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
Pediatric patients on hemodialysis or peritoneal dialysis with suspected or confirmed infection and who were receiving standard of care antibiotics were also eligible to receive a single dose of daptomycin 5mg/kg IV. Serial blood draws were obtained to assess daptomycin pharmacokinetics
Daptomycin IV 5 mg/kg one time dose
Other Name: Cubicin
- Maximum Plasma Concentration (Cmax) [ Time Frame: 0, 0.5, 2, 3, 4.5 6, 24, and 48 hours post dose ]
- Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC0-24) [ Time Frame: 0, 0.5, 2, 3, 4.5, 6, and 24 hours post dose ]
- Area Under the Concentration Time Curve From Time Zero to 48 Hours (AUC0-48) [ Time Frame: 0, 0.5, 2, 3, 4.5 6, 24, and 48 hours post dose ]
- Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-∞) [ Time Frame: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose ]
- Volume of Distribution at Steady State (Vss) [ Time Frame: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose ]The theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug
- Elimination Rate Constant (Ke) [ Time Frame: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose ]
- Total Drug Clearance (CLtotal) [ Time Frame: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose ]The rate at which a drug substance is removed from the body
- Drug Clearance Due to Dialysis (CLdialysis) [ Time Frame: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose ]The rate at which a drug substance is removed from the body due to dialysis therapy
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|