Vancomycin treatment in critically ill adults using model-informed precision dosing tool – prospective low-intervention clinical trial. (ProVanc)

Phase 1

Recruiting

Conditions: Serious infections where according to the treating physician's decision treatment with intravenous vancomycin is needed.
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: CTIS2023-509003-32-00

Lead Sponsor: Tartu University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 56

Inclusion Criteria

Age =18 years, Admitted to the tertiary intensive care unit in Tartu University Hospital, Patient has indication (assessed by treating doctor) to start intravenous vancomycin treatment

Exclusion Criteria

Patient has been previously enrolled into this study during ongoing hospital record, Patient has previously received vancomycin within last 7 days, Intravenous treatment with vancomycin has begun more than 24h before enrolment to study, The treating physician considers the patient not suitable for the study, There is no intention for vancomycin therapeutic drug monitoring, Continues intravenous vancomycin administration is used

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To prospectively evaluate the performance of the model selection and model-informed precision dosing tool developed by our study group in achieving desirable intravenous vancomycin exposure target over 70% of the treatment time.;Secondary Objective: To assess vancomycin treatment AUC24 based target attainment while doses are optimised using the model selection and model-informed precision dosing tool developed by our study group., To assess safety of the vancomycin model selection and model-informed precision dosing tool developed by our study group., To determine whether effective AUC24 can be achieved with concentrations in lower Ctrough based TDM range 10-15 mg/kg.;Primary end point(s): The proportion of patients that stay in the vancomycin therapeutic target range (AUC24 400-600 µg/ml x h) 70% of time when dose is optimised using the model selection and model-informed precision dosing tool developed by our study group

Secondary Outcome Measures