Concentration of Ertapenem in Colorectal Tissue

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Ulm
• Treatments: Ertapenem

Criteria

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.