Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by University of Oklahoma.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Cubist Pharmaceuticals
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01012089
First received: November 9, 2009
Last updated: April 2, 2012
Last verified: April 2012
  Purpose

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.

Condition Intervention
Chronic Kidney Disease
Bacterial Infection
Drug: Daptomycin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • To evaluate the pharmacokinetic profiles of a single 5 mg/kg dose of daptomycin IV in children who are on hemodialysis or peritoneal dialysis [ Time Frame: serial blood drug concentrations collected over the course of 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine urine, HD and PD clearance of daptomycin [ Time Frame: 28 Days ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: April 2010
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Daptomycin Drug: Daptomycin
Daptomycin IV 5 mg/kg one time dose
Other Name: Cubicin

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.

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01012089

Contacts
Contact: Teresa V Lewis, Pharm.D 405-271-2859 Teresa-Lewis@ouhsc.edu
Contact: Martin A Turman, M.D., Ph.D 405-271-4409 Martin-Turman@ouhsc.edu

Locations
United States, Oklahoma
The Children's Hospital at the University of Oklahoma Medical Center Recruiting
Oklahoma City, Oklahoma, United States, 73013
Contact: Teresa V Lewis, Pharm.D.    405-271-2859    Teresa-lewis@ouhsc.edu   
Principal Investigator: Teresa V Lewis, Pharm.D.         
Principal Investigator: Martin A Turman, M.D., Ph.D         
Sponsors and Collaborators
University of Oklahoma
Cubist Pharmaceuticals
Investigators
Principal Investigator: Teresa V Lewis, Pharm.D. University of Oklahoma
Principal Investigator: Martin A Turman, M.D., Ph.D. University of Oklahoma
  More Information

No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01012089     History of Changes
Other Study ID Numbers: 14808
Study First Received: November 9, 2009
Last Updated: April 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
Hemodialysis
Peritoneal dialysis
Daptomycin
Pharmacokinetics

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Bacterial Infections
Urologic Diseases
Renal Insufficiency
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014