Economic Evaluation of Vancomycin Therapeutic Drug Monitoring Methods

NCT ID: NCT04297176

Last Updated: 2022-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-23

Study Completion Date

2021-07-02

Brief Summary

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Vancomycin is a widely used antibiotic in the treatment of complicated gram positive infections. Approaches to vancomycin therapeutic drug monitioring (TDM) vary. This clinical trial aimed to compare the pharmacoeconomic outcomes between various vancomyicn TDM approaches.

Research questions: Which vancomycin therapeutic drug monitoring (TDM) approach is associated with superior economic outcomes?

-Objectives: In this proposed multicenter randomized controlled trial (RCT), we aim to compare the pharmacoeconomic outcomes of various vancomycin TDM approaches.

Detailed Description

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Conditions

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Infection, Bacterial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Traditional monitoring method

Patients are dosed using two timed vancomycin serum concentrations

Group Type EXPERIMENTAL

Vancomycin-traditional dosing

Intervention Type DRUG

The dose is calculated based on 2 vancomycin serum levels

One concentration method

Patients are dosed based on one timed vancomycin serum level

Group Type ACTIVE_COMPARATOR

Vancomycin- Trough-only based dosing

Intervention Type DRUG

The dose is calculated based on 1 vancomycin serum level (i.e. trough)

Interventions

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Vancomycin-traditional dosing

The dose is calculated based on 2 vancomycin serum levels

Intervention Type DRUG

Vancomycin- Trough-only based dosing

The dose is calculated based on 1 vancomycin serum level (i.e. trough)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adults at least 18 yrs who are hospitalized and initiated on IV vancomycin

Exclusion Criteria

* renal instability
* immunosuppression;
* vancomycin allergy;
* history of recurrent peritonitis
* administration of \< 4 doses of vancomycin
* pregnancy;
* hemoglobin \< 8 g/dL.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qatar University

OTHER

Sponsor Role collaborator

Hamad Medical Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Dr. Eman Zeyad Ibrahim Elmekaty

Clinical Pharmacist, Infectious Diseases Department, Communicable Diseases Center, Study Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hamad Medical Corporation

Doha, , Qatar

Site Status

Countries

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Qatar

Other Identifiers

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15418/15

Identifier Type: -

Identifier Source: org_study_id

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