Economic Evaluation of Vancomycin Therapeutic Drug Monitoring Methods

• Sponsor: Hamad Medical Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04297176
• Collaborator: Qatar University (Other)
• Enrollment: 65
• Location: 1
• Arms: 2
• Actual Duration (Months): 17.3
• Patients Per Site Per Month: 3.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Infection, Bacterial	Drug: Vancomycin-traditional dosing; Drug: Vancomycin- Trough-only based dosing	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 65 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Clinical and Economic Evaluation of Optimal Monitoring Parameters and Sampling Schemes for Vancomycin Therapeutic Drug Monitoring in Qatar
• Actual Study Start Date: Jan 23, 2020
• Actual Primary Completion Date: May 4, 2021
• Actual Study Completion Date: Jul 2, 2021

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hamad Medical Corporation	Doha		Qatar

Sponsors and Collaborators

• Hamad Medical Corporation
• Qatar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Eman Zeyad Ibrahim Elmekaty, Clinical Pharmacist, Infectious Diseases Department, Communicable Diseases Center, Study Principle Investigator, Hamad Medical Corporation
• ClinicalTrials.gov Identifier: NCT04297176
• Other Study ID Numbers: 15418/15
• First Posted: Mar 5, 2020
• Last Update Posted: Aug 15, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Bacterial Infections; Vancomycin

Study Results

No Results Posted as of Aug 15, 2022