Clinical trial NCT03560440: Evaluation of the Dosing Regimen of Vancomycin in Pediatric Patients
Official title: Evaluation of the Dosing Regimen of Vancomycin in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gram-Positive Bacterial Infections
Keywords: Vancomycin
Pharmacokinetics
Trough level
Pediatric
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 368
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients treated with vancomycin and hospitalized in UZ Leuven between January 2012 and April 2014

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.

Detailed description: 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. Patient files will be screened for relevant information. Individual patients can be included multiple times if vancomycin has been administered more than once.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Loading dose related plasma exposure vancomycin
timeFrame: 24 hours after loading dose
Secondary outcomes:
Other outcomes:
measure: Loading dose related plasma exposure vancomycin
timeFrame: 24 hours after dosage adjustment
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: UZ Leuven
name: Isabel Spriet, PharmD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.