Overview

Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease

Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Oklahoma
Collaborator:
Cubist Pharmaceuticals LLC
Treatments:
Daptomycin
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