Evaluation of the Dosing Regimen of Vancomycin in Pediatric Patients

Gram-Positive Bacterial Infections Clinical Trial

Official title:

Evaluation of the Dosing Regimen of Vancomycin in Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03560440
• Other study ID #: S56779
• Status: Completed
• Start date: June 2014
• Est. completion date: June 2017

Study information

• Verified date: June 2018
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 368
• Est. completion date: June 2017
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Bacterial Infections
• Gram-Positive Bacterial Infections

Intervention

Other:
• Plasma exposure vancomycin
Investigation of plasma exposure of vancomycin.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. Erratum in: Clin Infect Dis. 2009 Nov 1;49(9):1465. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Loading dose related plasma exposure vancomycin	Plasma exposure to vancomycin in relation to administered dose	24 hours after dosage adjustment
Primary	Loading dose related plasma exposure vancomycin	Plasma exposure to vancomycin in relation to administered dose	24 hours after loading dose