Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease

NCT ID: NCT01012089

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2014-04-30

Brief 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.

Detailed Description

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.

Conditions

Chronic Kidney Disease; Bacterial Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Daptomycin

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

Group Type: EXPERIMENTAL

Daptomycin

Intervention Type: DRUG

Daptomycin IV 5 mg/kg one time dose

Interventions

Daptomycin

Daptomycin IV 5 mg/kg one time dose

Intervention Type: DRUG

Other Intervention Names

Cubicin

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

INDUSTRY

Sponsor Role: collaborator

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teresa V Lewis, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Martin A Turman, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

The Children's Hospital at the University of Oklahoma Medical Center

Oklahoma City, Oklahoma, United States

Countries

United States

Other Identifiers

2375

Identifier Type: -

Identifier Source: org_study_id