Concentration of Ertapenem in Colorectal Tissue

Study Overview
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Brief Summary
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The purpose of this study is to determine the tissue kinetics of ertapenem in colonic tissue from three hours up to six hours (25% of dosing interval) after administration of ertapenem.

Detailed Description
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The purpose of this study is to determine the tissue kinetics of ertapenem in colorectal tissue from three hours up to six hours (25% of dosing interval) after administration of ertapenem before an elective surgical intervention (open or laparoscopic surgery) at the colon/rectum. Subjects are patients. Hospitalized patients 18 years or older requiring elective surgical intervention (open or laparoscopic surgery) at the colon will be eligible for this study.

Official Title
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Konzentrationen Von Ertapenem in Kolorektalem Gewebe

Conditions
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Diverticulosis, Colonic, Rectal Neoplasms, Colonic Neoplasms

Intervention / Treatment
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* Drug: Ertapenem


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 the colon will be eligible for this study. Patients with benignant disorders (e.g. colonic diverticulosis) will be preferred. Exclusion Criteria: Pregnancy or lactation in women Emergency surgery, history of serious allergy or intolerance to β-lactam antibiotics and other carbapenems 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 Chronic immunosuppressive therapy 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 and coagulation studies (INR) > 1.5 x ULN, ongoing therapy with valproin acid.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ertapenem<br>Administration of 1 gram ertapenem I.V. | Drug: Ertapenem<br>* powder for infusion, 1 gram I.V., single dose over 30 min.<br>* Other names: ATC code: J01DH03;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of Ertapenem in Colorectal Tissue in mg/kg 3 to 6 Hours After a Single Dose of 1 Gram Ertapenem I.V.. |  | 3 to 6 hours after a single dose of 1 gram ertapenem I.V.. | 
| Tissue (Total) Concentrations of Ertapenem in the Colorectal Tissue | The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue every 30 minutes up to 10 hours | The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue as an average of every 30 miuntes up to 10 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Assessment |  | 0 to approx. 14 days after admission |