Clinical and Economic Evaluation of Optimal Monitoring Parameters and Sampling Schemes for Vancomycin Therapeutic Drug Monitoring in Qatar
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- cost-benefit
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults at least 18 yrs who are hospitalized and initiated on IV vancomycin
排除标准
- •renal instability
- •immunosuppression;
- •vancomycin allergy;
- •history of recurrent peritonitis
- •administration of < 4 doses of vancomycin
- •pregnancy;
- •hemoglobin < 8 g/dL.
研究组 & 干预措施
Traditional monitoring method
Patients are dosed using two timed vancomycin serum concentrations
干预措施: Vancomycin-traditional dosing (Drug)
One concentration method
Patients are dosed based on one timed vancomycin serum level
干预措施: Vancomycin- Trough-only based dosing (Drug)
结局指标
主要结局
cost-benefit
时间窗: 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.
therapeutic success
时间窗: 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.
次要结局
未报告次要终点
研究者
Dr. Eman Zeyad Ibrahim Elmekaty
Clinical Pharmacist, Infectious Diseases Department, Communicable Diseases Center, Study Principle Investigator
Hamad Medical Corporation