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Use of a Loading Dose of Vancomycin in Pediatric Dosing

Information source: Children's Hospital Boston
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infection

Intervention: intravenous vancomycin hydrochloride (Drug)

Phase: N/A

Status: Terminated

Sponsored by: Children's Hospital Boston

Official(s) and/or principal investigator(s):
Alicia A Demirjian, MD, Principal Investigator, Affiliation: Children's Hospital Boston


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.

Clinical Details

Official title: The Use of a Loading Dose of Intravenous Vancomycin Will Achieve Therapeutic Concentration Earlier Than Conventional Pediatric Dosing: A Randomized Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: 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

Secondary outcome: pharmacokinetic parameters for vancomycin in the study population


Minimum age: 2 Years. Maximum age: 18 Years. Gender(s): Both.


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

Locations and Contacts

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

Related 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. doi: 10.2146/ajhp080434. Review. 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. doi: 10.1097/INF.0b013e3181906e40.

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; Infectious Diseases Society of America. 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 1;52(3):e18-55. doi: 10.1093/cid/ciq146. Epub 2011 Jan 4. Erratum in: Clin Infect Dis. 2011 Aug 1;53(3):319.

Starting date: February 2011
Last updated: March 8, 2012

Page last updated: August 23, 2015

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