An interventional study of Daptomycin in Chronic Kidney Disease and Bacterial Infection, sponsored by University of Oklahoma. Completed at 1 site in United States. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2018-06-06.
Sponsored by University of Oklahoma · Not applicable, Interventional, and Other
The purpose of this study is to:
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.
658 studies on the registry are indexed under Bacterial Infections; 100 are open to participants now.
This study's enrollment of 6 is below the median of 84 across 405 interventional studies indexed under Bacterial Infections.
Browse Bacterial Infections studies →University of Oklahoma is the lead sponsor of 424 studies on the registry; 99 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: Daptomycin
Daptomycin IV 5 mg/kg one time dose
Also known as: 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)
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
Time frame: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose
Elimination Rate Constant (Ke)
Time frame: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose
Total Drug Clearance (CLtotal)
The rate at which a drug substance is removed from the body
Time frame: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose
Drug Clearance Due to Dialysis (CLdialysis)
The rate at which a drug substance is removed from the body due to dialysis therapy
Time frame: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose
| Milestone | Daptomycin |
|---|---|
| Started | 6 |
| Completed | 6 |
| Not completed | 0 |
| mg/L | Daptomycin Hemodialysis | Daptomycin Peritoneal Dialysis |
|---|---|---|
| Maximum Plasma Concentration (Cmax) | 42.4 (36.1 to 46.5) | 66.5 (45.1 to 97.8) |
| mg∙hr/L | Daptomycin Hemodialysis | Daptomycin Peritoneal Dialysis |
|---|---|---|
| Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC0-24) | 388 (323 to 429) | 708 (525 to 944) |
| mg∙hr/L | Daptomycin Hemodialysis | Daptomycin Peritoneal Dialysis |
|---|---|---|
| Area Under the Concentration Time Curve From Time Zero to 48 Hours (AUC0-48) | 557 (454 to 617) | 1051 (804 to 1412) |
| mg∙hr/L | Daptomycin Hemodialysis | Daptomycin Peritoneal Dialysis |
|---|---|---|
| Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-∞) | 734 (579 to 874) | 1477 (1142 to 2127) |
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
| L | Daptomycin Hemodialysis | Daptomycin Peritoneal Dialysis |
|---|---|---|
| Volume of Distribution at Steady State (Vss) | 5.89 (4.68 to 6.99) | 6.38 (6.23 to 6.49) |
| hr-1 | Daptomycin Hemodialysis | Daptomycin Peritoneal Dialysis |
|---|---|---|
| Elimination Rate Constant (Ke) | 0.0053 (0.00358 to 0.00777) | 0.00848 (0.00848 to 0.00848) |
The rate at which a drug substance is removed from the body
| mL/hr | Daptomycin Hemodialysis | Daptomycin Peritoneal Dialysis |
|---|---|---|
| Total Drug Clearance (CLtotal) | 177 (150 to 221) | 170 (143 to 208) |
The rate at which a drug substance is removed from the body due to dialysis therapy
| mL/hr | Daptomycin Hemodialysis | Daptomycin Peritoneal Dialysis |
|---|---|---|
| Drug Clearance Due to Dialysis (CLdialysis) | 670 (646 to 690) | 21 (18 to 23) |
Collected over Safety assessments were performed on study "Day 0", "Day 1", "Day 2". Serum CPK and standard clinical laboratory evaluations were obtained at baseline and at the end of study "Day 0". A telephone follow-up was also conducted by study personnel at Day 7, 14, 21 and 28 post study drug administration to continue follow-up of potential adverse events.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Daptomycin Peritoneal Dialysis | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Daptomycin Hemodialysis | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Age, Categorical(Participants) | Daptomycin Hemodialysis | Daptomycin Peritoneal Dialysis | Total |
|---|---|---|---|
| <=18 years | 3 | 3 | 6 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Daptomycin Hemodialysis | Daptomycin Peritoneal Dialysis | Total |
|---|---|---|---|
| Mean | 15.3 (14 to 17) | 13.7 (12 to 15) | 14.5 (12 to 17) |
| Sex: Female, Male(Participants) | Daptomycin Hemodialysis | Daptomycin Peritoneal Dialysis | Total |
|---|---|---|---|
| Female | 0 | 1 | 1 |
| Male | 3 | 2 | 5 |
| Region of Enrollment(participants) | Daptomycin Hemodialysis | Daptomycin Peritoneal Dialysis | Total |
|---|---|---|---|
| United States | 3 | 3 | 6 |
Plan to share: Undecided
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University of Oklahoma