Economic Evaluation of Vancomycin Therapeutic Drug Monitoring Methods

Hamad Medical Corporation (HMC)

Status: Completed

Conditions: Infection, Bacterial

Treatments: Drug: Vancomycin-traditional dosing; Drug: Vancomycin- Trough-only based dosing

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04297176

15418/15

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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65 participants in 2 patient groups

Traditional monitoring method

Experimental group

Description:

Patients are dosed using two timed vancomycin serum concentrations

Treatment:

Drug: Vancomycin-traditional dosing

One concentration method

Active Comparator group

Description:

Patients are dosed based on one timed vancomycin serum level

Treatment:

Drug: Vancomycin- Trough-only based dosing