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Concentration of Ertapenem in Colorectal Tissue

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase IV Biomarker/Laboratory analysis, Treatment Active 18 to 90 Other 01-07
NCT00535652

Trial Description

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.

Further Study Information

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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

Doris Henne-Bruns, Prof. Dr.

Principal Investigator

Doris Henne-Bruns, Prof. Dr.		Ph: +49(0)73150053500
		Email: doris.henne-bruns@uniklinik-ulm.de

Mathias Wittau, Dr.		Ph: +49(0)73150053594
		Email: mathias.wittau@uniklinik-ulm.de

Trial Sites

Germany

Ulm

Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

Doris Henne-Bruns, Prof. Dr. Ph: +49(0)73150053500

Email: doris.henne-bruns@uniklinik-ulm.de

Mathias Wittau, Dr. Ph: +49(0)73150053500

Email: mathias.wittau@uniklinik-ulm.de

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00535652
Information obtained from ClinicalTrials.gov on March 18, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.