Evaluation of the Dosing Regimen of Vancomycin in Pediatric Patients

NCT03560440 | Completed

• 1 other identifier: S56779
• Study Type: observational
• Target: 368
• Locations: 1 country
• Sites: 1

Brief Summary

In this retrospective registry the investigators wish to verify whether the current dosing regime of vancomycin is leading to the appropriate pharmacokinetic targets in pediatric patients. Therefore data will be collected from all pediatric patients hospitalized in University Hospitals Leuven between January 2012 and April 2014 who were treated with vancomycine.

Conditions

Gram-Positive Bacterial Infections

Keywords

Vancomycin; Pharmacokinetics; Trough level; Pediatric

Outcome Measures

Primary Outcomes (1)

• Loading dose related plasma exposure vancomycin

  Plasma exposure to vancomycin in relation to administered dose

  24 hours after loading dose

Other Outcomes (1)

• Loading dose related plasma exposure vancomycin

  24 hours after dosage adjustment

Study Arms (1)

Plasma exposure vancomycin

Pediatric patients treated with vancomycin

Other: Plasma exposure vancomycin

Interventions

Plasma exposure vancomycin OTHER

Investigation of plasma exposure of vancomycin.

Plasma exposure vancomycin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients treated with vancomycin and hospitalized in UZ Leuven between January 2012 and April 2014

You may qualify if:

• Pediatric patients hospitalized in the University Hospitals Leuven between January 2012 and April 2014, treated with vancomycin

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

Related Publications (5)

• Rybak MJ, Lomaestro BM, Rotschafer JC, Moellering RC, Craig WA, Billeter M, Dalovisio JR, Levine DP. Vancomycin therapeutic guidelines: a summary of consensus recommendations from the infectious diseases Society of America, the American Society of Health-System Pharmacists, and the Society of Infectious Diseases Pharmacists. Clin Infect Dis. 2009 Aug 1;49(3):325-7. doi: 10.1086/600877.

  PMID: 19569969 BACKGROUND

• Piro CC, Crossno CL, Collier A, Ho R, Koyama T, Frangoul H. Initial vancomycin dosing in pediatric oncology and stem cell transplant patients. J Pediatr Hematol Oncol. 2009 Jan;31(1):3-7. doi: 10.1097/MPH.0b013e31818b3520.

  PMID: 19125078 BACKGROUND

• Glover ML, Cole E, Wolfsdorf J. Vancomycin dosage requirements among pediatric intensive care unit patients with normal renal function. J Crit Care. 2000 Mar;15(1):1-4. doi: 10.1053/jcrc.2000.0150001.

  PMID: 10757191 BACKGROUND

• Kim DI, Im MS, Choi JH, Lee J, Choi EH, Lee HJ. Therapeutic monitoring of vancomycin according to initial dosing regimen in pediatric patients. Korean J Pediatr. 2010 Dec;53(12):1000-5. doi: 10.3345/kjp.2010.53.12.1000. Epub 2010 Dec 31.

  PMID: 21253314 BACKGROUND

• Ito H, Shime N, Kosaka T. Pharmacokinetics of glycopeptide antibiotics in children. J Infect Chemother. 2013 Apr;19(2):352-5. doi: 10.1007/s10156-012-0458-8. Epub 2012 Aug 8.

  PMID: 22872188 BACKGROUND

MeSH Terms

Conditions

Gram-Positive Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Isabel Spriet, PharmD PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PharmD PhD

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: June 18, 2018
• Study Start: June 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: June 1, 2017
• Last Updated: June 18, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)