Dose individualization of Beta-lactam and fluoroquinolone antibiotics in ICU patients: to TDM or not to TDM and the effects on Outcome
- Conditions
- Intensive care, Antibiotics, Pharmacodynamics, Pharmacokinetics
- Registration Number
- NL-OMON21680
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 250
Inclusion Criteria
≥18 years of age
- Receiving intravenous antibiotic therapy of the target drugs
Exclusion Criteria
- Pregnancy
- Patient already enrolled in this trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacodynamic target attainment:<br /><br>- Beta-lactam: %ƒT>MIC(ECOFF) (including % of patients with 100%ƒT>MIC(ECOFF) in both groups).<br>- Fluoroquinolone: ƒAUC/MIC(ECOFF) (including % of patients with ƒAUC/MIC(ECOFF)≥100 in both groups)
- Secondary Outcome Measures
Name Time Method To determent if active TDM results in improved clinical outcome, increased cost-effectiveness, better quality of life and less post-ICU syndrome.<br /><br>- Clinical outcomes are 28-day mortality, SOFA (sequential organ failure assessment score, use of other antibiotics, readmittance and procalcitonin decrease.<br /><br>- Cost-effectiveness will be determined directly (costs of stay at ICU, including treatment costs) and using appropriate health – economic analysis. <br>