Economic Evaluation of Vancomycin Therapeutic Drug Monitoring Methods

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

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.

Study Overview

• Status: Completed
• Conditions: Infection, Bacterial
• Intervention / Treatment: Drug: Vancomycin-traditional dosing; Drug: Vancomycin- Trough-only based dosing

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Qatar
  • Doha, Qatar
    • Hamad Medical Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hamad Medical Corporation
• Collaborators: Qatar University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 23, 2020
• Primary Completion (ACTUAL): May 4, 2021
• Study Completion (ACTUAL): July 2, 2021

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (ACTUAL): March 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 15, 2022
• Last Update Submitted That Met QC Criteria: August 11, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Bacterial Infections; Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin
• Other Study ID Numbers: 15418/15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No