Real-World Evidence: cefiderocol therapeutic drug monitoring in
critically ill, obese patients in NDM infections
Abstract
Background and Purpose: Cefiderocol (FDC) application on critically ill
patients is still limited: recommended dosing regimens are usually
derived from studies on healthy subjects, but critical illness is always
associated with physio/pathological alterations in patients, resulting
in drug concentration perturbation. Furthermore, there is a scant
real-life data addressing particular sub-populations, like
morbidly/obese and augmented renal clearance patients, making
pharmacokinetics/pharmacodynamics (PK/PD) target recommendation debated.
The aim of this study was to present FDC PK/PD values in patients from
morbidly to pathologically obese and with augmented renal clearance.
Experimental Approach: Ten patients with K. pneumoniae NDM infections
were enrolled. Plasma therapeutic drug monitoring was performed after
steady-state at different timings. The conventional PK/PD target of
fT>MIC has been considered, along with a more aggressive
target of fT>6 x MIC; evaluated clinical outcomes were
microbiological eradication and 30 days mortality. Key Results: A
correlation between weight and 30 days mortality was highlighted. The
percentage of failure in achieving the microbiological eradication
progressively increased with higher BMI. Furthermore, 100% patients
reached the conventional PK/PD target of fCmin>4 mg/L; while,
when evaluating a more aggressive target of 100% fT>6 x MIC
(2 mg/L), different factors showed an influence as FDC minimum free
concentration, area under the concentration time curve and drug
clearance. Conclusion and Implications: Our study may be useful in
real-world evidence, highlighting the important influence of BMI and
high value of clearance in achieving the microbiological target,
suggesting that further study and the use of therapeutic drug monitoring
in this context are needed.