Konzentrationen von Ertapenem in kolorektalem Gewebe.

• Conditions: 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 a 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.; MedDRA version: 9.1Level: LLTClassification code 10049086Term: Antibacterial prophylaxis

• Registration Number: EUCTR2007-001565-15-DE
• Lead Sponsor: niversityhospital Ulm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-28
• Last Update Posted: 18 February 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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. Twenty patients requiring abdominal surgery at the colon will be enrolled in this study. Patients with benignant disorders (e.g. colonic diverticulosis) will be prefered. Conventional therapies will not be changed during the study period.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnancy or lactation in women, emergency surgery, history of serious allergy or intolerance to ß-lactam antibiotics, 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified