External Evaluation of Vancomycin Population Pharmacokine... | NCT05481788

Studies
External Evaluation of Vancomycin Population Pharmacokinetic Models

NCT05481788

Sponsor

University Hospital, Brest

Status

Completed

Last Update Posted

Aug 1, 2022Actual

Enrollment

300Actual

Phase

Not provided

Conditions

Vancomycin Dosage

Interventions

Not provided

Countries

France

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

Jul 2022

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

Apr 16, 2021Actual

Primary Completion Date

Oct 1, 2021Actual

Completion Date

Nov 1, 2021Actual

First Submitted Date

Jun 18, 2021

First Submission Date that Met QC Criteria

Jul 28, 2022

First Posted Date

Aug 1, 2022Actual

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

Jul 28, 2022

Last Update Posted Date

Aug 1, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

All patients treated with vancomycin hospitalized outside of ICU in Brest University Hospital from 1rst january 2019 to 1rst january 2021 will be screened for inclusion. Vancomycin dosage, age, weight and serum creatinin will be recorded.

Seven pharmacokinetic models' predictive performance will be evaluated on this database.

Using the best model, we will perform Monte-Carlo simulation to elaborate dosing nomograms and develop dosing recommandations of continuous infusion of vancomycin.

Detailed Description

Monte Carlo simulations will be performed according to varying creatinin clearance values and weight, for both the loading dose and the maintenance dose.

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

300Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Imprecision in Predictive performance of seven pharmacokinetic models	The model with the lesser imprecision reported on the Observed vs Predicted Concentrations Graph will be selected	September 2021
Bias in Predictive performance of seven pharmacokinetic models	The model with the lesser bias reported on the Observed vs Predicted Concentrations Graph will be selected	September 2021

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients hospitalized in Brest University Hospital,
treated with vancomycin and receiving pharmacological monitoring
between 1rst January 2019 and 1rst January 2021

Exclusion Criteria:

Missing data on vancomycin administration
Refusal to be included in this study
Hospitalisation in ICU

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All adults treated with vancomycin outside of ICU

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brest University Hospital		Brest		29200	France