Economic Evaluation of Vancomycin Therapeutic Drug Monitoring Methods

Infection, Bacterial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04297176
• Other study ID #: 15418/15
• Status: Completed
• Phase: N/A
• Start date: January 23, 2020
• Est. completion date: July 2, 2021

Study information

• Verified date: August 2022
• Source: Hamad Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: July 2, 2021
• Est. primary completion date: May 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Infections
• Infection, Bacterial

Intervention

Drug:
• Vancomycin-traditional dosing
The dose is calculated based on 2 vancomycin serum levels
• Vancomycin- Trough-only based dosing
The dose is calculated based on 1 vancomycin serum level (i.e. trough)

Locations

Country	Name	City	State
Qatar	Hamad Medical Corporation	Doha

Sponsors (2)

Lead Sponsor	Collaborator
Hamad Medical Corporation	Qatar University

Country where clinical trial is conducted

Qatar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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