Infection, Bacterial
Conditions
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.
Interventions
DRUGVancomycin-traditional dosing
The dose is calculated based on 2 vancomycin serum levels
DRUGVancomycin- Trough-only based dosing
The dose is calculated based on 1 vancomycin serum level (i.e. trough)
Sponsors
Qatar University
Hamad Medical Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Qatar
Outcome results
None listed