Clinical trial NCT00535652: Concentration of Ertapenem in Colorectal Tissue
Official title: Konzentrationen Von Ertapenem in Kolorektalem Gewebe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diverticulosis, Colonic
Rectal Neoplasms
Colonic Neoplasms
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2007-09-26
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Concentration of Ertapenem in Colorectal Tissue in mg/kg 3 to 6 Hours After a Single Dose of 1 Gram Ertapenem I.V..
timeFrame: 3 to 6 hours after a single dose of 1 gram ertapenem I.V..
measure: Tissue (Total) Concentrations of Ertapenem in the Colorectal Tissue
timeFrame: The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue as an average of every 30 miuntes up to 10 hours
Secondary outcomes:
measure: Safety Assessment
timeFrame: 0 to approx. 14 days after admission
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: University of Ulm, Dept. of Visceral Surgery
Study officials:
affiliation: University of Ulm, Dept. of Visceral Surgery
name: Doris Henne-Bruns, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wittau M, Scheele J, Bulitta JB, Mayer B, Kaever V, Burhenne H, Henne-Bruns D, Isenmann R, Brockschmidt C. Pharmacokinetics of ertapenem in colorectal tissue. Chemotherapy. 2011;57(5):437-48. doi: 10.1159/000333377. Epub 2011 Dec 22.