Use of a Loading Dose of Vancomycin in Pediatric Dosing

NCT01290237 | Terminated Results

• 1 other identifier: 10-11-0561
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infection

Keywords

vancomycin; loading dose; pharmacokinetic; pediatric; Methicillin-Resistant Staphylococcus aureus (MRSA); Serious infection with Gram positive bacteria

Outcome Measures

Primary Outcomes (1)

• Count of Participants With Vancomycin Trough Between 15 and 20

  proportion of participants whose vancomycin trough was between 15 and 20 mcg/mL, 8 hours after the first vancomycin dose, in loading dose group as compared to control group

  8 hours after the first dose of vancomycin

Secondary Outcomes (1)

• AUC/MIC for Vancomycin in the Study Population

  within 48 hours after receiving the first dose of vancomycin

Study Arms (2)

Vancomycin loading dose

EXPERIMENTAL

Intervention: administer intravenous vancomycin 30 mg/kg/dose once, followed 8 hours later by 20 mg/kg/dose every 8 hours

Drug: vancomycin hydrocloride

Control

ACTIVE COMPARATOR

No intervention. Administer intravenous vancomycin 20 mg/kg/dose every 8 hours as per hospital guideline.

Drug: vancomycin hydrocloride

Interventions

vancomycin hydrocloride DRUG

see description of study arms

Also known as: Vancomycin

Control; Vancomycin loading dose

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Related Publications (4)

• 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. No abstract available.

  PMID: 19106348 BACKGROUND

• 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.

  PMID: 19295465 BACKGROUND

• 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.

  PMID: 21208910 BACKGROUND

• Demirjian A, Finkelstein Y, Nava-Ocampo A, Arnold A, Jones S, Monuteaux M, Sandora TJ, Patterson A, Harper MB. A randomized controlled trial of a vancomycin loading dose in children. Pediatr Infect Dis J. 2013 Nov;32(11):1217-23. doi: 10.1097/INF.0b013e3182a26774.

  PMID: 23817340 DERIVED

MeSH Terms

Conditions

Infections

Interventions

Vancomycin

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

* trial underpowered to detect an increase of ≥40% in concentrations (small sample size) * more cases excluded in the high-dose group than in reference group (possible analysis bias) * increase in red man syndrome in the high-dose group

Results Point of Contact

• Title: Dr. Alicia Demirjian
• Organization: Boston Children's Hospital

alicia.demirjian@post.harvard.edu

Study Officials

• Alicia A Demirjian, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Fellow, Pediatric Infectious Diseases

Study Record Dates

• First Submitted: January 28, 2011
• First Posted: February 4, 2011
• Study Start: February 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: March 1, 2012
• Last Updated: June 19, 2018
• Results First Posted: March 5, 2018

Record last verified: 2018-05

Locations

US (1)