Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease

NCT01012089 | Completed Results DMC

• 1 other identifier: 2375
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to:

1. 1.Study the pharmacokinetics and safety of daptomycin in children on hemodialysis (HD) and peritoneal dialysis (PD).
2. 2.Determine urine, HD and PD clearance of daptomycin.

Conditions

Chronic Kidney Disease; Bacterial Infection

Keywords

Hemodialysis; Peritoneal dialysis; Daptomycin; Pharmacokinetics

Outcome Measures

Primary Outcomes (8)

• Maximum Plasma Concentration (Cmax)

  0, 0.5, 2, 3, 4.5 6, 24, and 48 hours post dose

• Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC0-24)

  0, 0.5, 2, 3, 4.5, 6, and 24 hours post dose

• Area Under the Concentration Time Curve From Time Zero to 48 Hours (AUC0-48)

  0, 0.5, 2, 3, 4.5 6, 24, and 48 hours post dose

• Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-∞)

  0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose

• 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

  0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose

• Elimination Rate Constant (Ke)

  0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose

• Total Drug Clearance (CLtotal)

  The rate at which a drug substance is removed from the body

  0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose

• Drug Clearance Due to Dialysis (CLdialysis)

  The rate at which a drug substance is removed from the body due to dialysis therapy

  0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose

Study Arms (1)

Daptomycin

EXPERIMENTAL

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

Interventions

Daptomycin DRUG

Daptomycin IV 5 mg/kg one time dose

Also known as: Cubicin

Daptomycin

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead
• Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): collaborator

Study Sites (1)

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

Oklahoma City, Oklahoma, 73013, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Bacterial Infections

Interventions

Daptomycin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Teresa Lewis Pharm D
• Organization: University of Oklahoma College of Pharmacy

Teresa-Lewis@ouhsc.edu

405-271-2859

Study Officials

• Teresa V Lewis, Pharm.D.

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

• Martin A Turman, M.D., Ph.D.

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2009
• First Posted: November 11, 2009
• Study Start: November 1, 2009
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 6, 2018
• Results First Posted: June 6, 2018

Record last verified: 2018-05

Locations

US (1)