Economic Evaluation of Vancomycin Therapeutic Drug Monitoring Methods

Study Overview
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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.

Official Title
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Clinical and Economic Evaluation of Optimal Monitoring Parameters and Sampling Schemes for Vancomycin Therapeutic Drug Monitoring in Qatar

Conditions
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Infection, Bacterial

Intervention / Treatment
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* Drug: Vancomycin-traditional dosing
* Drug: Vancomycin- Trough-only based dosing


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Traditional monitoring method<br>Patients are dosed using two timed vancomycin serum concentrations | Drug: Vancomycin-traditional dosing<br>* The dose is calculated based on 2 vancomycin serum levels<br>|
| Active Comparator: One concentration method<br>Patients are dosed based on one timed vancomycin serum level | Drug: Vancomycin- Trough-only based dosing<br>* The dose is calculated based on 1 vancomycin serum level (i.e. trough)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| therapeutic success | Therapeutic success will be assessed as therapeutic cure (composite endpoint)or therapeutic failure (composite endpoint). Therapeutic cure is defined as clinical cure and/or microbiologic cure . Clinical cure is defined as the absence of infection signs/symptoms without the need for additional antibiotic treatment. Microbiologic cure is defined as negative blood cultures at 5 days after vancomycin treatment initiation. Therapeutic failure includes at least one of the following -clinical failure, microbiologic failure, premature discontinuation due to ADR or all-cause mortality. Clinical failure is defined as insufficient clinical response to initial vancomycin therapy necessitating antibiotic change. Microbiological failure is defined as a positive culture at ≥ 5 days after initiation of vancomycin treatment. | The follow up time varies according to the infection type. It ranges from 7 days to 1 month. | 
| cost-benefit | The hospital and treatment related costs will be compared between the two study arms, from a hospital perspective, associating the clinical outcomes mentioned in Outcome 1 above. The arm showing least costs will be determined as more beneficial to the healthcare system. | Ranges from 7 days to 1 month, according to the infection type and possible antibiotic changes if treatment failure occurs |