We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Use of a Loading Dose of Vancomycin in Pediatric Dosing

This study has been terminated.
(PI leaving institution, slow enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01290237
First Posted: February 4, 2011
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alicia Demirjian, Children's Hospital Boston
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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:


Further study details as provided by Alicia Demirjian, 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 ]

Secondary Outcome Measures:
  • pharmacokinetic parameters for vancomycin in the study population [ Time Frame: within 48 hours after receiving the first dose of vancomycin ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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): NCT01290237


Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Investigators
Principal Investigator: Alicia A Demirjian, MD Boston Children’s Hospital
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: January 28, 2011
First Posted: February 4, 2011
Last Update Posted: October 12, 2017
Last Verified: March 2012

Keywords provided by Alicia Demirjian, 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