Economic Evaluation of Vancomycin Therapeutic Drug Monitoring Methods

NCT04297176 | Completed DMC

• 1 other identifier: 15418/15
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection, Bacterial

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Traditional monitoring method

EXPERIMENTAL

Patients are dosed using two timed vancomycin serum concentrations

Drug: Vancomycin-traditional dosing

One concentration method

ACTIVE COMPARATOR

Patients are dosed based on one timed vancomycin serum level

Drug: Vancomycin- Trough-only based dosing

Interventions

Vancomycin-traditional dosing DRUG

The dose is calculated based on 2 vancomycin serum levels

Traditional monitoring method

Vancomycin- Trough-only based dosing DRUG

The dose is calculated based on 1 vancomycin serum level (i.e. trough)

One concentration method

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults at least 18 yrs who are hospitalized and initiated on IV vancomycin

You may not qualify if:

• renal instability
• immunosuppression;
• vancomycin allergy;
• history of recurrent peritonitis
• administration of \< 4 doses of vancomycin
• pregnancy;
• hemoglobin \< 8 g/dL.

Sponsors & Collaborators

• Hamad Medical Corporation: lead
• Qatar University: collaborator

Study Sites (1)

Hamad Medical Corporation

Doha, Qatar

Location

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacist, Infectious Diseases Department, Communicable Diseases Center, Study Principle Investigator

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 5, 2020
• Study Start: January 23, 2020
• Primary Completion: May 4, 2021
• Study Completion: July 2, 2021
• Last Updated: August 15, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)