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Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease

Primary Purpose

Chronic Kidney Disease, Bacterial Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Daptomycin
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Kidney Disease focused on measuring Hemodialysis, Peritoneal dialysis, Daptomycin, Pharmacokinetics

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Daptomycin

Arm Description

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

Outcomes

Primary Outcome Measures

Maximum Plasma Concentration (Cmax)
Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC0-24)
Area Under the Concentration Time Curve From Time Zero to 48 Hours (AUC0-48)
Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-∞)
Volume of Distribution at Steady State (Vss)
The theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug
Elimination Rate Constant (Ke)
Total Drug Clearance (CLtotal)
The rate at which a drug substance is removed from the body
Drug Clearance Due to Dialysis (CLdialysis)
The rate at which a drug substance is removed from the body due to dialysis therapy

Secondary Outcome Measures

Full Information

First Posted
November 9, 2009
Last Updated
May 3, 2018
Sponsor
University of Oklahoma
Collaborators
Cubist Pharmaceuticals LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01012089
Brief Title
Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease
Official Title
Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
Collaborators
Cubist Pharmaceuticals LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to: Study the pharmacokinetics and safety of daptomycin in children on hemodialysis (HD) and peritoneal dialysis (PD). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Bacterial Infection
Keywords
Hemodialysis, Peritoneal dialysis, Daptomycin, Pharmacokinetics

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Daptomycin
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Daptomycin
Other Intervention Name(s)
Cubicin
Intervention Description
Daptomycin IV 5 mg/kg one time dose
Primary Outcome Measure Information:
Title
Maximum Plasma Concentration (Cmax)
Time Frame
0, 0.5, 2, 3, 4.5 6, 24, and 48 hours post dose
Title
Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC0-24)
Time Frame
0, 0.5, 2, 3, 4.5, 6, and 24 hours post dose
Title
Area Under the Concentration Time Curve From Time Zero to 48 Hours (AUC0-48)
Time Frame
0, 0.5, 2, 3, 4.5 6, 24, and 48 hours post dose
Title
Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-∞)
Time Frame
0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose
Title
Volume of Distribution at Steady State (Vss)
Description
The theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug
Time Frame
0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose
Title
Elimination Rate Constant (Ke)
Time Frame
0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose
Title
Total Drug Clearance (CLtotal)
Description
The rate at which a drug substance is removed from the body
Time Frame
0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose
Title
Drug Clearance Due to Dialysis (CLdialysis)
Description
The rate at which a drug substance is removed from the body due to dialysis therapy
Time Frame
0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa V Lewis, Pharm.D.
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin A Turman, M.D., Ph.D.
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital at the University of Oklahoma Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease

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