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OpenTrials
Completed

NCT Number: NCT04297176

Economic Evaluation of Vancomycin Therapeutic Drug Monitoring Methods

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamad Medical Corporation

Doha, Qatar

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vancomycin-traditional dosing

Drug

The dose is calculated based on 2 vancomycin serum levels

Vancomycin- Trough-only based dosing

Drug

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

Primary outcomes

  1. therapeutic success

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hamad Medical Corporation

Industry

Collaborators

  • Qatar University

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 5, 2020
Registry last updated
Aug 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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