PK of Caspofungin in ICU septic patients might be changed as compared to healthy volunteers due to sepsis-related pathophysiology. Sub-optimal plasma and tissue concentrations might be achieved in these patients when drugs are administered at the same dosage/regimen suggested for healthy volunteers.
Open non randomized, non controlled single center study on the pharmacokinetics of caspofungin in 20 consecutive ICU patients with severe sepsis or septic shock, requiring caspofungin therapy and PK-PD evaluation for the optimization of caspofungin therapy. The aim of this study is to describe the Caspofungin PK-PD alterations in a cohort of critically ill septic patients.
Study Type
OBSERVATIONAL
Enrollment
20
In accordance with routine clinical practice, Caspofungin will be given at the loading dose of 70 mg followed by 50 mg daily (for people \< 80 kg body weight). No dose reduction will be performed in Child-Pugh score A or B. Duration of therapy will be performed in accordance with ESCMID guidelines and clinical conditions.
Alterations of Caspofungin Area Under the curve (AUC) in septic patients admitted to the Intensive Care Unit (ICU).
The caspofungin AUC will be described and compared with that reported in the literature for healthy volunteers.
Time frame: first 24 hours after loading dose
Alterations of Cmax/MIC target - which guarantees the maximal exposure of Candida spp to caspofungin
The Cmax/MIC ratio, will be calculated and compared with that reported in the literature to obtain the infection eradication.
Time frame: first 24 hours after loading dose
Alterations of Cmax/MIC target - which guarantees the maximal exposure of Candida spp to caspofungin
The Cmax/MIC ratio, will be calculated and compared with that reported in the literature to obtain the infection eradication.
Time frame: at day 4 after loading dose
Alterations of AUC/MIC target - which guarantees the maximal exposure of Candida spp to caspofungin
The AUC/MIC ratio, will be calculated and compared with that reported in the literature to obtain the infection eradication.
Time frame: first 24 hours after loading dose
Alterations of AUC/MIC target - which guarantees the maximal exposure of Candida spp to caspofungin
The AUC/MIC ratio, will be calculated and compared with that reported in the literature to obtain the infection eradication.
Time frame: at day 4 after loading dose
Alterations of Caspofungin maximum serum concentrations in septic patients admitted to the Intensive Care Unit (ICU).
The caspofungin maximum serum concentrations will be described and compared with those reported in the literature for healthy volunteers.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: first 24 hours after loading dose
Alterations of Caspofungin maximum serum concentrations in septic patients admitted to the Intensive Care Unit (ICU).
The caspofungin maximum serum concentrations will be described and compared with those reported in the literature for healthy volunteers.
Time frame: at day 4 after loading dose
Alterations of Caspofungin minimum serum concentrations in septic patients admitted to the Intensive Care Unit (ICU).
The caspofungin minimum serum concentrations will be described and compared with those reported in the literature for healthy volunteers.
Time frame: first 24 hours after loading dose
Alterations of Caspofungin minimum serum concentrations in septic patients admitted to the Intensive Care Unit (ICU).
The caspofungin minimum serum concentrations will be described and compared with those reported in the literature for healthy volunteers.
Time frame: at day 4 after loading dose
Alterations of Caspofungin volume distribution in septic patients admitted to the Intensive Care Unit (ICU).
The caspofungin volume distribution will be described and compared with those reported in the literature for healthy volunteers.
Time frame: first 24 hours after loading dose
Alterations of Caspofungin volume distribution in septic patients admitted to the Intensive Care Unit (ICU).
The caspofungin volume distribution will be described and compared with those reported in the literature for healthy volunteers.
Time frame: at day 4 after loading dose
Alterations of Caspofungin elimination half life in septic patients admitted to the Intensive Care Unit (ICU).
The caspofungin elimination half life will be described and compared with those reported in the literature for healthy volunteers.
Time frame: first 24 hours after loading dose
Alterations of Caspofungin elimination half life in septic patients admitted to the Intensive Care Unit (ICU).
The caspofungin elimination half life will be described and compared with those reported in the literature for healthy volunteers.
Time frame: at day 4 after loading dose
Alterations of Caspofungin Area Under the curve (AUC) in septic patients admitted to the Intensive Care Unit (ICU).
The caspofungin AUC will be described and compared with that reported in the literature for healthy volunteers.
Time frame: at day 4 after loading dose