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| Name | Class |
|---|---|
| Qatar University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional monitoring method | Experimental | Patients are dosed using two timed vancomycin serum concentrations |
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| One concentration method | Active Comparator | Patients are dosed based on one timed vancomycin serum level |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vancomycin-traditional dosing | Drug | The dose is calculated based on 2 vancomycin serum levels |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamad Medical Corporation | Doha | Qatar |
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| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Vancomycin- Trough-only based dosing | Drug | The dose is calculated based on 1 vancomycin serum level (i.e. trough) |
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