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Completed

NCT Number: NCT01012089

Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease

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.

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Key information

Conditions

Chronic Kidney Disease Bacterial Infection Bacterial Infections Bacterial Infections and Mycoses Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Oklahoma City, Oklahoma, 73013, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

daptomycin

Drug

Daptomycin IV 5 mg/kg one time dose

Other names: Cubicin

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

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

Registry information

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Nov 11, 2009
Registry last updated
Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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