Concentration of Ertapenem in Colorectal Tissue
This study has been completed.
Information provided by:
University of Ulm
First received: September 24, 2007
Last updated: April 5, 2010
Last verified: February 2009
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.
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Konzentrationen Von Ertapenem in Kolorektalem Gewebe
Primary Outcome Measures:
- Concentration of ertapenem in colorectal tissue in mg/kg 3 to 6 hours after a single dose of 1 gram ertapenem I.V.. [ Time Frame: 3 to 6 hours after a single dose of 1 gram ertapenem I.V.. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- safety assessment [ Time Frame: 0 to approx. 14 days after admission ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2009 (Final data collection date for primary outcome measure)
Administration of 1 gram ertapenem I.V.
powder for infusion, 1 gram I.V., single dose over 30 min.
- Invanz, EU/1/02/216/001 + /002
- ATC code: J01DH03
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.
|Ages Eligible for Study:
||18 Years to 90 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00535652
|University of Ulm, Dept. of Visceral Surgery
|Ulm, Germany, 89075 |
University of Ulm
||Doris Henne-Bruns, Prof. Dr.
||University of Ulm, Dept. of Visceral Surgery
No publications provided
||Prof. Dr. R. Marre, Universityhospital Ulm
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 24, 2007
||April 5, 2010
||Germany: Federal Institute for Drugs and Medical Devices
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 26, 2014
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Pathological Conditions, Anatomical