Concentration of Ertapenem in Colorectal Tissue

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-12-31

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.

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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.

Conditions

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Diverticulosis, Colonic Rectal Neoplasms Colonic Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ertapenem

Administration of 1 gram ertapenem I.V.

Group Type EXPERIMENTAL

Ertapenem

Intervention Type DRUG

powder for infusion, 1 gram I.V., single dose over 30 min.

Interventions

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Ertapenem

powder for infusion, 1 gram I.V., single dose over 30 min.

Intervention Type DRUG

Other Intervention Names

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Invanz, EU/1/02/216/001 + /002 ATC code: J01DH03

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No