Pharmacometrics Prediction Personalized medicine Antibiotics Sepsis Infectious disease Infectieziekten Farmacokinetiek Farmacometrie
Conditions
Interventions
Patients will be randomized to one of two groups.
Group 1 (Control group): standard intravenous antibiotic therapy based on current clinical guidelines and practice. Standard therapy will include TDM
Sponsors
VU University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Age >18 years - Suspected or confirmed infection - Treatment or planned treatment with one or more of the following antibiotics: vancomycin, ceftriaxone, meropenem, ciprofloxacine, cefotaxime.
Exclusion criteria
Exclusion criteria: none
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK target attainment in the first 24-hours. Targets are 100%-fT>4MIC for the beta-lactam antibiotics, fAUC/ MIC>400 for vancomycin and fAUC/MIC ≥125 for ciprofloxacin | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to PK target level, PK target attainment during therapy, attainment of clinical cure, length of ICU and hospital stay, delta Sequential Organ Failure Assessment (SOFA) score at 96 hours, days free of ventilator / hemofiltration / other organ support, ICU / hospital / 28 day / 6-month mortality, quality of life at hospital discharge (EQ-5D-5L) and after 6 months, societal costs (iMTA MCQ and iMTA PCQ on admission versus after 6 months), days free of delirium. | — |
Contacts
Public ContactB. van Dijk
Outcome results
None listed