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