Use of a Loading Dose of Vancomycin in Pediatric Dosing

This study has been terminated.

(PI leaving institution, slow enrollment)

Sponsor:

Information provided by (Responsible Party):

Alicia Demirjian, Children's Hospital Boston

ClinicalTrials.gov Identifier:

NCT01290237

First received: January 28, 2011

Last updated: March 8, 2012

Last verified: March 2012

History of Changes

Purpose

Vancomycin is an antibiotic administered to children or adults for many types of infections. While it has been used to treat infections of children for more than 50 years we are still not completely certain about the best dose to use when starting treatment with this medication.

This study is intended to evaluate whether giving a new higher dose of vancomycin for the first dose will help us get to the desired amount in the body more quickly then the usual first dose. Half of the patients would get the new higher dose and the other half of patients will get the typical first dose. Only the first dose is changed and all doses that follow are the same in both groups and are doses typically used for children.

Condition	Intervention
Infection	Drug: intravenous vancomycin hydrochloride

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	The Use of a Loading Dose of Intravenous Vancomycin Will Achieve Therapeutic Concentration Earlier Than Conventional Pediatric Dosing: A Randomized Controlled Trial

Resource links provided by NLM:

Drug Information available for: Vancomycin Vancomycin hydrochloride

U.S. FDA Resources

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:

proportion of patients whose vancomycin trough reached 15 mcg/mL, 8 hours after the first vancomycin dose, in loading dose group as compared to control group [ Time Frame: 8 hours after the first dose of vancomycin ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

pharmacokinetic parameters for vancomycin in the study population [ Time Frame: within 48 hours after receiving the first dose of vancomycin ] [ Designated as safety issue: No ]
mean volume of distribution (to be measured in L) and mean elimination rate constant (to be measured in hour^-1) for vancomycin

Enrollment:	59
Study Start Date:	February 2011
Study Completion Date:	March 2012
Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Vancomycin loading dose Intravenous vancomycin 30 mg/kg/dose once, followed 8 hours later by 20 mg/kg/dose every 8 hours	Drug: intravenous vancomycin hydrochloride see description of study arms
Active Comparator: Control Intravenous vancomycin 20 mg/kg/dose every 8 hours	Drug: intravenous vancomycin hydrochloride see description of study arms

Eligibility

Ages Eligible for Study:	2 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Receiving care at Children's Hospital Boston
Prescribed intravenous vancomycin by their physician

Exclusion Criteria:

Weight above 67 kg
Pre-existing renal dysfunction (creatinine clearance < 50 ml/min/1.73m2)
Known hearing impairment
Recent intravenous vancomycin treatment (within 7 days)
Undergoing procedure with anticipated moderate-severe blood loss

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01290237

Locations

United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Children's Hospital Boston

Investigators

Principal Investigator:

Alicia A Demirjian, MD

Children's Hospital Boston

More Information

Publications:

Rybak M, Lomaestro B, Rotschafer JC, Moellering R Jr, Craig W, Billeter M, Dalovisio JR, Levine DP. Therapeutic monitoring of vancomycin in adult patients: a consensus review of the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, and the Society of Infectious Diseases Pharmacists. Am J Health Syst Pharm. 2009 Jan 1;66(1):82-98. Review. No abstract available. Erratum in: Am J Health Syst Pharm. 2009 May 15;66(10):887.

Frymoyer A, Hersh AL, Benet LZ, Guglielmo BJ. Current recommended dosing of vancomycin for children with invasive methicillin-resistant Staphylococcus aureus infections is inadequate. Pediatr Infect Dis J. 2009 May;28(5):398-402.

Liu C, Bayer A, Cosgrove SE, Daum RS, Fridkin SK, Gorwitz RJ, Kaplan SL, Karchmer AW, Levine DP, Murray BE, J Rybak M, Talan DA, Chambers HF. Clinical practice guidelines by the infectious diseases society of america for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children. Clin Infect Dis. 2011 Feb;52(3):e18-55. Epub 2011 Jan 4.

Responsible Party:	Alicia Demirjian, Clinical Fellow, Pediatric Infectious Diseases, Children's Hospital Boston
ClinicalTrials.gov Identifier:	NCT01290237 History of Changes
Other Study ID Numbers:	10-11-0561
Study First Received:	January 28, 2011
Last Updated:	March 8, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:

vancomycin
loading dose
pharmacokinetic

pediatric
Methicillin-Resistant Staphylococcus aureus (MRSA)
Serious infection with Gram positive bacteria

Additional relevant MeSH terms:

Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013

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