Pharmacokinetics of Carbapenem Antibiotics in Obese Patients.

University of Ulm

Status and phase: Completed; Phase 4

Conditions: Obesity

Treatments: Procedure: microdialysis catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT01407965

2010-024094-39 (EudraCT Number)

Adip-2010

Details and patient eligibility

About

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

Full description

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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Ertapenem

Experimental group

Description:

Free tissue kinetics of ertapenem in fatty tissue and intraperitoneal fluid in mg/L Free and bound plasma concentration of ertapenem or meropenem in mg/L

Treatment:

Procedure: microdialysis catheter

Procedure: microdialysis catheter

Meropenem

Experimental group

Description:

Free tissue kinetics of meropenem in fatty tissue and intraperitoneal fluid in mg/L up to 24 hours after administration. Free and bound plasma concentration of meropenem in mg/L.

Treatment:

Procedure: microdialysis catheter

Procedure: microdialysis catheter