Concentration of Ertapenem in Colorectal Tissue
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Konzentrationen Von Ertapenem in Kolorektalem Gewebe|
- 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 ]
- safety assessment [ Time Frame: 0 to approx. 14 days after admission ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2007|
|Study Completion Date:||December 2009|
|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.
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.
|University of Ulm, Dept. of Visceral Surgery|
|Ulm, Germany, 89075|
|Principal Investigator:||Doris Henne-Bruns, Prof. Dr.||University of Ulm, Dept. of Visceral Surgery|