Concentration of Ertapenem in Colorectal Tissue - Full Text View

Sponsored by:	University of Ulm
Information provided by:	University of Ulm
ClinicalTrials.gov Identifier:	NCT00535652

Purpose

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.

Condition	Intervention	Phase
Diverticulosis, Colonic Rectal Neoplasms Colonic Neoplasms	Drug: Ertapenem	Phase IV

MedlinePlus related topics: Cancer

Drug Information available for: L 749345 Ertapenem

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title:	Konzentrationen Von Ertapenem in Kolorektalem Gewebe

Further study details as provided by University of Ulm:

Primary Outcome Measures:

Concentration of ertapenem in colorectal tissue in mg/kg 3 to 6 hours after a single dose of 1 gram ertapenem I.V.. [ Time Frame: 3 to 6 hours after a single dose of 1 gram ertapenem I.V.. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

safety assessment [ Time Frame: 0 to approx. 14 days after admission ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	September 2007
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Ertapenem: Experimental Administration of 1 gram ertapenem I.V.	Drug: Ertapenem powder for infusion, 1 gram I.V., single dose over 30 min.

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

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00535652

Contacts

Contact: Doris Henne-Bruns, Prof. Dr.	+49(0)73150053500	doris.henne-bruns@uniklinik-ulm.de
Contact: Mathias Wittau, Dr.	+49(0)73150053594	mathias.wittau@uniklinik-ulm.de

Locations

Germany
University of Ulm, Dept. of Visceral Surgery	Recruiting
Ulm, Germany, 89075
Contact: Doris Henne-Bruns, Prof. Dr. +49(0)73150053500 doris.henne-bruns@uniklinik-ulm.de
Contact: Mathias Wittau, Dr. +49(0)73150053500 mathias.wittau@uniklinik-ulm.de

Sponsors and Collaborators

University of Ulm

Investigators

Principal Investigator:

Doris Henne-Bruns, Prof. Dr.

University of Ulm, Dept. of Visceral Surgery

More Information

No publications provided

Responsible Party:	Universityhospital Ulm ( Prof. Dr. R. Marre )
Study ID Numbers:	01-07
Study First Received:	September 24, 2007
Last Updated:	February 13, 2009
ClinicalTrials.gov Identifier:	NCT00535652 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Rectal Neoplasm
Diverticulum
Intestinal Diseases
Rectal Diseases

Intestinal Neoplasms
Ertapenem
Anti-Bacterial Agents
Rectal Cancer
Digestive System Diseases
Gastrointestinal Neoplasms
Diverticulosis, Colonic
Colonic Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Anti-Infective Agents
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Diverticulum
Rectal Diseases
Pharmacologic Actions
Intestinal Neoplasms

Ertapenem
Anti-Bacterial Agents
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Neoplasms
Diverticulosis, Colonic
Colonic Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009