Hamad Medical Corporation
Doha, Qatar
NCT Number: NCT04297176
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Doha, Qatar
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The dose is calculated based on 2 vancomycin serum levels
The dose is calculated based on 1 vancomycin serum level (i.e. trough)
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.
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.
Hamad Medical Corporation
Industry
Clinical and Economic Evaluation of Optimal Monitoring Parameters and Sampling Schemes for Vancomycin Therapeutic Drug Monitoring in Qatar
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.
Published trials that share one or more normalized conditions with this study.
NCT02992951
Bacterial Infections, Bacterial Infections and Mycoses
Hull, East Riding of Yorkshire, United Kingdom
View Trial DetailsNCT05960006
Antibiotic Toxicity, Ascites Hepatic
Amsterdam, Netherlands
View Trial DetailsNCT04894500
Bacterial Infections, Bacterial Infections and Mycoses
Prague, Czechia
View Trial DetailsNCT03163628
Bacterial Infections, Bacterial Infections and Mycoses
Bron, France
View Trial Details