An interventional study of Vancomycin-traditional dosing and Vancomycin- Trough-only based dosing in Infection, Bacterial, sponsored by Hamad Medical Corporation. Completed at 1 site in Qatar. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-15.
Sponsored by Hamad Medical Corporation · Not applicable, Interventional, and Treatment
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.
658 studies on the registry are indexed under Bacterial Infections; 100 are open to participants now.
This study's enrollment of 65 is below the median of 84 across 405 interventional studies indexed under Bacterial Infections.
Browse Bacterial Infections studies →Hamad Medical Corporation is the lead sponsor of 133 studies on the registry; 24 are open to participants now.
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Exclusion Criteria:
Patients are dosed using two timed vancomycin serum concentrations
Drug: Vancomycin-traditional dosing
Patients are dosed based on one timed vancomycin serum level
Drug: Vancomycin- Trough-only based dosing
The dose is calculated based on 2 vancomycin serum levels
The dose is calculated based on 1 vancomycin serum level (i.e. trough)
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.
Time frame: 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.
Time frame: Ranges from 7 days to 1 month, according to the infection type and possible antibiotic changes if treatment failure occurs
Plan to share: No
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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Hamad Medical Corporation