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