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Concentration of Ertapenem in Colorectal Tissue

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ClinicalTrials.gov Identifier: NCT00535652
Recruitment Status : Completed
First Posted : September 26, 2007
Results First Posted : December 16, 2016
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
M. Wittau, University of Ulm

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diverticulosis, Colonic Rectal Neoplasms Colonic Neoplasms Drug: Ertapenem Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Konzentrationen Von Ertapenem in Kolorektalem Gewebe
Study Start Date : September 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.. ]
  2. Tissue (Total) Concentrations of Ertapenem in the Colorectal Tissue [ Time Frame: The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue as an average of every 30 miuntes up to 10 hours ]
    The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue every 30 minutes up to 10 hours


Secondary Outcome Measures :
  1. Safety Assessment [ Time Frame: 0 to approx. 14 days after admission ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00535652


Locations
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Germany
University of Ulm, Dept. of Visceral Surgery
Ulm, Germany, 89075
Sponsors and Collaborators
University of Ulm
Investigators
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Principal Investigator: Doris Henne-Bruns, Prof. Dr. University of Ulm, Dept. of Visceral Surgery
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: M. Wittau, MD, University of Ulm
ClinicalTrials.gov Identifier: NCT00535652    
Other Study ID Numbers: 01-07
First Posted: September 26, 2007    Key Record Dates
Results First Posted: December 16, 2016
Last Update Posted: February 10, 2017
Last Verified: December 2016
Additional relevant MeSH terms:
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Neoplasms
Rectal Neoplasms
Colonic Neoplasms
Diverticulum
Diverticular Diseases
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
Gastroenteritis
Pathological Conditions, Anatomical
Ertapenem
Anti-Bacterial Agents
Anti-Infective Agents