Economic Evaluation of Vancomycin Therapeutic Drug Monitoring Methods

Not Applicable

Completed

• Conditions: Infection, Bacterial
• Interventions: Drug: Vancomycin-traditional dosing; Drug: Vancomycin- Trough-only based dosing

• Registration Number: NCT04297176
• Lead Sponsor: Hamad Medical Corporation

Brief Summary

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

Not available

Study Timeline

• Study Start: 2020-01-23
• Study First Submitted: 2020-03-02
• Study First Submitted QC: 2020-03-03
• Study First Posted: 2020-03-05
• Primary Completion: 2021-05-04
• Study Completion: 2021-07-02
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-11
• Last Update Posted: 2022-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional monitoring method	Vancomycin-traditional dosing	Patients are dosed using two timed vancomycin serum concentrations
One concentration method	Vancomycin- Trough-only based dosing	Patients are dosed based on one timed vancomycin serum level

Primary Outcome Measures

Name	Time	Method
cost-benefit	Ranges from 7 days to 1 month, according to the infection type and possible antibiotic changes if treatment failure occurs	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.
therapeutic success	The follow up time varies according to the infection type. It ranges from 7 days to 1 month.	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.

Trial Locations

Locations (1)

Hamad Medical Corporation; 🇶🇦 Doha, Qatar