Pharmacokinetics of Carbapenem Antibiotics in Obese Patients.

Offene, Monozentrische, Nicht Kontrollierte Und Nicht Randomisierte Phase IV-Studie Zur Bestimmung Der Pharmakokinetik Von Carbapenemen in adipösen Patienten.

Tissue kinetics of ertapenem and meropenem in fatty tissue, intraperitoneal fluid and plasma.

The purpose of this study is to determine the free tissue kinetics of ertapenem and meropenem in fatty tissue and intraperitoneal fluid up to 24 hours after administration of the IMP.

Inclusion Criteria:

• Hospitalized patients 18 years or older requiring elective surgical intervention (open or laparoscopic surgery) at intraabdominal organs
• BMI more or even 40
• written informed consent

Exclusion Criteria:

• BMI < 40
• pregnancy or lactation in women
• emergency surgery
• history of serious allergy or intolerance to β-lactam antibiotics
• systemic antimicrobial therapy with ceftazidime (internal standard of high-performance liquid chromatography / mass spectrometry) within a 7 days period prior to study entry
• ongoing intraabdominal infections
• terminal illness
• severe diseases of the liver, e.g. cirrhosis of the liver with ALT or AST > 6 x upper limit of normal (ULN) and bilirubin > 3 x ULN
• severe renal insufficiency with a creatinine clearance ≤30 mL/min.
• neutrophil count < 1000 cells/mm3
• platelets < 75000 cells/mm3
• coagulation studies (INR) > 1.5 x ULN
• ongoing chemotherapy and/or radiotherapy
• ongoing therapy with valproin acid (in case of ertapenem administration).