Evaluation of the Dosing Regimen of Vancomycin in Pediatr... | NCT03560440

Studies
Evaluation of the Dosing Regimen of Vancomycin in Pediatric Patients

NCT03560440

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Last Update Posted

Jun 18, 2018Actual

Enrollment

368Actual

Phase

Not provided

Conditions

Gram-Positive Bacterial Infections

Interventions

Plasma exposure vancomycin

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Feb 2016Actual

Completion Date

Jun 2017Actual

First Submitted Date

Nov 29, 2016

First Submission Date that Met QC Criteria

Jun 6, 2018

First Posted Date

Jun 18, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2018

Last Update Posted Date

Jun 18, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Isabelle Spriet, PharmD PhD, Universitaire Ziekenhuizen KU LeuvenPrincipal Investigator

Lead Sponsor

Universitaire Ziekenhuizen KU LeuvenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

368Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Plasma exposure vancomycin		Pediatric patients treated with vancomycin	Other: Plasma exposure vancomycin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Plasma exposure vancomycin	Other	Investigation of plasma exposure of vancomycin.	Plasma exposure vancomycin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Loading dose related plasma exposure vancomycin	Plasma exposure to vancomycin in relation to administered dose	24 hours after loading dose

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Loading dose related plasma exposure vancomycin	Plasma exposure to vancomycin in relation to administered dose	24 hours after dosage adjustment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Isabel Spriet, PharmD PhD	UZ Leuven	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UZ Leuven		Leuven		3000	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19569969	Background	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.
19125078

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections