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Economic Evaluation of Vancomycin Therapeutic Drug Monitoring Methods

Primary Purpose

Infection, Bacterial

Status
Completed
Phase
Not Applicable
Locations
Qatar
Study Type
Interventional
Intervention
Vancomycin-traditional dosing
Vancomycin- Trough-only based dosing
Sponsored by
Hamad Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infection, Bacterial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hamad Medical Corporation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Traditional monitoring method

One concentration method

Arm Description

Patients are dosed using two timed vancomycin serum concentrations

Patients are dosed based on one timed vancomycin serum level

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 2, 2020
Last Updated
August 11, 2022
Sponsor
Hamad Medical Corporation
Collaborators
Qatar University
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1. Study Identification

Unique Protocol Identification Number
NCT04297176
Brief Title
Economic Evaluation of Vancomycin Therapeutic Drug Monitoring Methods
Official Title
Clinical and Economic Evaluation of Optimal Monitoring Parameters and Sampling Schemes for Vancomycin Therapeutic Drug Monitoring in Qatar
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 23, 2020 (Actual)
Primary Completion Date
May 4, 2021 (Actual)
Study Completion Date
July 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hamad Medical Corporation
Collaborators
Qatar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Bacterial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional monitoring method
Arm Type
Experimental
Arm Description
Patients are dosed using two timed vancomycin serum concentrations
Arm Title
One concentration method
Arm Type
Active Comparator
Arm Description
Patients are dosed based on one timed vancomycin serum level
Intervention Type
Drug
Intervention Name(s)
Vancomycin-traditional dosing
Intervention Description
The dose is calculated based on 2 vancomycin serum levels
Intervention Type
Drug
Intervention Name(s)
Vancomycin- Trough-only based dosing
Intervention Description
The dose is calculated based on 1 vancomycin serum level (i.e. trough)
Primary Outcome Measure Information:
Title
therapeutic success
Description
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.
Title
cost-benefit
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hamad Medical Corporation
City
Doha
Country
Qatar

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Economic Evaluation of Vancomycin Therapeutic Drug Monitoring Methods

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