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Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease

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ClinicalTrials.gov Identifier: NCT01012089
Recruitment Status : Completed
First Posted : November 11, 2009
Results First Posted : June 5, 2018
Last Update Posted : June 5, 2018
Sponsor:
Collaborator:
Cubist Pharmaceuticals LLC
Information provided by (Responsible Party):
University of Oklahoma

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Bacterial Infection Drug: Daptomycin Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease
Study Start Date : November 2009
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Daptomycin

Arm Intervention/treatment
Experimental: 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
Drug: Daptomycin
Daptomycin IV 5 mg/kg one time dose
Other Name: Cubicin




Primary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) [ Time Frame: 0, 0.5, 2, 3, 4.5 6, 24, and 48 hours post dose ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. Volume of Distribution at Steady State (Vss) [ Time Frame: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose ]
    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

  6. Elimination Rate Constant (Ke) [ Time Frame: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose ]
  7. Total Drug Clearance (CLtotal) [ Time Frame: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose ]
    The rate at which a drug substance is removed from the body

  8. Drug Clearance Due to Dialysis (CLdialysis) [ Time Frame: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose ]
    The rate at which a drug substance is removed from the body due to dialysis therapy



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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01012089


Locations
United States, Oklahoma
The Children's Hospital at the University of Oklahoma Medical Center
Oklahoma City, Oklahoma, United States, 73013
Sponsors and Collaborators
University of Oklahoma
Cubist Pharmaceuticals LLC
Investigators
Principal Investigator: Teresa V Lewis, Pharm.D. University of Oklahoma
Principal Investigator: Martin A Turman, M.D., Ph.D. University of Oklahoma

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01012089     History of Changes
Other Study ID Numbers: 2375
First Posted: November 11, 2009    Key Record Dates
Results First Posted: June 5, 2018
Last Update Posted: June 5, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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