Concentration of Ertapenem in Colorectal Tissue

University of Ulm

Status and phase

Completed

Phase 4

Conditions

Diverticulosis, Colonic

Colonic Neoplasms

Rectal Neoplasms

Treatments

Drug: Ertapenem

Study type

Interventional

Funder types

Other

Identifiers

NCT00535652

01-07

Details and patient eligibility

About

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.

Full description

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.

Enrollment

23 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.