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: 9.1 Level: LLT Classif
Conditions
Interventions
Trade Name: Invanz
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Ertapenem
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1-
Sponsors
Universityhospital Ulm
Eligibility
Sex/Gender
All
Inclusion 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. 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
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 1.5 x ULN.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: ;Primary end point(s): Tissue kinetics of ertapenem in colonic tissue from three hours up to six hours after single administration of ertapenem. | — |
Countries
Germany
Outcome results
None listed