Concentration of Ertapenem in Colorectal Tissue

This study has been completed.
Sponsor:
Information provided by:
University of Ulm
ClinicalTrials.gov Identifier:
NCT00535652
First received: September 24, 2007
Last updated: April 5, 2010
Last verified: February 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Konzentrationen Von Ertapenem in Kolorektalem Gewebe

Resource links provided by NLM:


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 ]

Enrollment: 23
Study Start Date: September 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ertapenem
Administration of 1 gram ertapenem I.V.
Drug: Ertapenem
powder for infusion, 1 gram I.V., single dose over 30 min.
Other Names:
  • Invanz, EU/1/02/216/001 + /002
  • ATC code: J01DH03

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

Locations
Germany
University of Ulm, Dept. of Visceral Surgery
Ulm, Germany, 89075
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: Prof. Dr. R. Marre, Universityhospital Ulm
ClinicalTrials.gov Identifier: NCT00535652     History of Changes
Other Study ID Numbers: 01-07
Study First Received: September 24, 2007
Last Updated: April 5, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Neoplasms
Rectal Neoplasms
Colonic Neoplasms
Diverticulum
Diverticulosis, Colonic
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases
Pathological Conditions, Anatomical
Ertapenem
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014