University of Ulm, Dept. of Visceral Surgery
Ulm, 89075, Germany
NCT Number: NCT00535652
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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Notify Me18 year–90 year
All sexes
Interventional
Phase 4
Ulm, 89075, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
powder for infusion, 1 gram I.V., single dose over 30 min.
Other names: Invanz, EU/1/02/216/001 + /002, ATC code: J01DH03
Time frame: 3 to 6 hours after a single dose of 1 gram ertapenem I.V..
Time frame: The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue as an average of every 30 miuntes up to 10 hours
The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue every 30 minutes up to 10 hours
Time frame: 0 to approx. 14 days after admission
University of Ulm
Other
Konzentrationen Von Ertapenem in Kolorektalem Gewebe
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