Therapeutic Drug Monitoring in Patients With Difficult-to-Treat Gram-Negative Bacterial Infections (TDM-RCT)
Sepsis, Hemodynamic Instability, Bacterial Infections
About this trial
This is an interventional treatment trial for Sepsis focused on measuring Sepsis, Hemodynamic Instability, Therapeutic Drug Monitoring, Gram-negative Bacteria, Beta-Lactams, Fosfomycin, Fluoroquinolone, Glycylcycline, Dialysis
Eligibility Criteria
Inclusion Criteria: 16 years or older Receive intravenous therapy of the study antibiotics Antibiotic treatment should be aimed for at least 3 days at time of inclusion Exclusion Criteria: Pregnancy Antibiotics cessation before first blood sample collection Receiving antibiotics only as prophylaxis On palliative care or with less than 48 hours of life expectancy
Sites / Locations
- Singapore General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Control
Intervention
The prescription of antibiotics will follow institution antibiotic prescribing guidelines or at the Infectious Disease (ID) clinician's discretion, based on culture and antibiotic susceptibilities results (whenever available). Empiric antibiotic treatment will be employed prior to the availability of culture or antibiotic susceptibilities results. Antibiotic level measurements, Minimum Inhibitory Concentrations (MIC) testing and Pharmacokinetics/Pharmacodynamics (PK/PD) target analysis will only be performed at Day 14 post enrolment, but the results will not be released to the ID clinician and the primary clinician.
Once a positive GNB culture is known, antibiotic MIC testing will commence, and PK/PD target analysis will be performed using the antibiotic MIC. An every-other-day TDM-guided regimen will be chosen to rapidly adjust the antibiotic doses until the PK/PD target is achieved. In the event the antibiotic dose readjustment is unable to achieve the defined PK/PD target, blood sampling will continue every other day until Day 14 or the PK/PD target is achieved