Pharmacokinetics of Carbapenem Antibiotics in Obese Patients.

Study Overview
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Brief Summary
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Tissue kinetics of ertapenem and meropenem in fatty tissue, intraperitoneal fluid and plasma.

Detailed Description
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Procedure: microdialysis catheter
* Procedure: microdialysis catheter


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ertapenem<br>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 | Procedure: microdialysis catheter<br>* Placing of microdialysis catheter in fatty tissue and in the peritoneal cavity<br>|
| Experimental: Meropenem<br>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. | Procedure: microdialysis catheter<br>* Placing of microdialysis catheter in fatty tissue and in the peritoneal cavity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unbound concentration of ertapenem and meropenem in fatty tissue and peritoneal fluid |  | within 24 h after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events (total and per patient) |  | Participants will be followed for the duration of hospital stay, an expected average of 3 weeks | 
| Number of Serious Adverse Events (total and per patient) |  | Participants will be followed for the duration of hospital stay, an expected average of 3 weeks | 
| Number of Suspected Unexpected Serious Adverse Reactions (SUSARs) |  | Participants will be followed for the duration of hospital stay, an expected average of 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, pharmacokinetic, ertapenem, meropenem