Meropenem and imipenem are broad-spectrum carbapenem antibiotic and are frequently prescribed in critically ill patients with severe infections. These patients show several pathophysiological changes that may alter the carbapenem pharmacokinetic (PK) normally found in other populations. Although the PK of carbapenems has been widely studied, most studies have been conducted on small populations, and clinical outcome data are sparse. Therefore, the aims of this study are (i) describe the population pharmacokinetic parameters of meropenem and imipenem in critically ill subject (ii) evaluate the pharmacodynamic of meropenem and imipenem as a predictor of clinical treatment outcome.
Study Type
OBSERVATIONAL
Enrollment
102
This group is composed of 52 critically ill patients, meropenem dosage is chosen by the intensivist in charge of the case. Blood sampling: 5 blood samples (3 mL) were obtained from a heparinized intravascular catheter by direct venipuncture at the following time: before (time 0) and during 0-0.5 h, 0.5-2.5 h, 2.5-4 h, 4-8 h or 4-12 after meropenem administration.
This group is composed of 50 critically ill patients, imipenem dosage is chosen by the intensivist in charge of the case. Blood sampling: 5 blood samples (3 mL) were obtained from a heparinized intravascular catheter by direct venipuncture at the following time: before (time 0) and during 0-0.5 h, 0.5-2 h, 2-4 h, 4-6 h or 4-12 after imipenem administration.
Faculty of Medicine, Prince of Songkla University, Thailand
Hat Yai, Changwat Songkhla, Thailand
RECRUITINGPopulation pharmacokinetic parameters of meropenem and imipenem
Time frame: 24-48 hours after treatment
%fT>MIC of meropenem and imipenem
the percentage of time which the free drug concentration remains above the minimum inbibitory concentration (%fT\>MIC)
Time frame: 24-48 hours after treatment
The relationship between %fT>MIC and clinical cure
Clinical cure: disappearance of all signs and symptoms related to the infection, such that no additional antibacterial therapy, drainage, or surgical procedure was required.
Time frame: Day 3-7 after treatment and end of therapy (7-14)
The relationship between %fT>MIC and microbiological cure
Success is eradication (absence of the baseline pathogen in a specimen appropriately obtained from the original site of infection) or presumed eradication (absence of material to culture in a subject who was assessed as a clinical cure).
Time frame: Day 3-7 after treatment and end of therapy (7-14)
The relationship between %fT>MIC and mortality
All-cause mortality
Time frame: during hospital stay and at day 28
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