N/A
N=6
Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease
Chronic Kidney Disease · Bacterial Infection
Bottom Line
View on ClinicalTrials.gov: NCT01012089 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcome: Primary: Maximum Plasma Concentration (Cmax) — 42.4; 66.5 mg/L
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Daptomycin (Drug)
- Age
- Pediatric · 12+ yrs
- Sex
- All
- Sponsor
- University of Oklahoma
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration (Cmax) |
42.4; 66.5 | — |
| PRIMARY Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC0-24) |
388; 708 | — |
| PRIMARY Area Under the Concentration Time Curve From Time Zero to 48 Hours (AUC0-48) |
557; 1051 | — |
| PRIMARY Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-∞) |
734; 1477 | — |
| PRIMARY Volume of Distribution at Steady State (Vss) |
5.89; 6.38 | — |
| PRIMARY Elimination Rate Constant (Ke) |
0.0053; 0.00848 | — |
| PRIMARY Total Drug Clearance (CLtotal) |
177; 170 | — |
| PRIMARY Drug Clearance Due to Dialysis (CLdialysis) |
670; 21 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Children who are between 12-17 years of age who are either on HD or PD and whom the Pediatric Nephrology Section of the OU Children's Physicians Clinics provide care.
- In addition to children on chronic HD and PD therapy, patients newly initiated on HD and PD will also be recruited for this study.
- Patients with suspected or confirmed cases of dialysis related infection from gram-positive bacteria and who are receiving standard of care antibiotics.
- Patients will be eligible for enrollment if they were admitted as an inpatient to the Children's hospital or as an outpatient to the dialysis clinic
Exclusion Criteria
- Patients > 17 years of age
- Patients < 12 years of age
- Total amount of blood drawn as part of standard of care and for pharmacokinetic analysis exceeds 3 ml/kg over an 8 week period
- Taking an HMG CoA reductase inhibitor within 7 days of daptomycin administration
- Having used daptomycin in the 30 days preceding study entry
- Participating in any experimental procedure in the 30 days preceding study
- A history of muscular disease or neurological disease
- Baseline creatine phosphokinase (CPK) values equal to or greater than 1.5 times the upper limit of normal (normal range 65-370 IU/L)
- Hemoglobin < 9 g/dl
- Hemodynamic instability within 72 hours before study enrollment
- Female subjects with a positive pregnancy test or failure to take a pregnancy test
Data sourced from ClinicalTrials.gov (NCT01012089). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.