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Concentration of Ertapenem in Colorectal Tissue

Primary Purpose

Diverticulosis, Colonic, Rectal Neoplasms, Colonic Neoplasms

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Ertapenem
Sponsored by
University of Ulm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diverticulosis, Colonic

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Ulm, Dept. of Visceral Surgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ertapenem

Arm Description

Administration of 1 gram ertapenem I.V.

Outcomes

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..
Tissue (Total) Concentrations of Ertapenem in the Colorectal Tissue
The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue every 30 minutes up to 10 hours

Secondary Outcome Measures

Safety Assessment

Full Information

First Posted
September 24, 2007
Last Updated
December 16, 2016
Sponsor
University of Ulm
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1. Study Identification

Unique Protocol Identification Number
NCT00535652
Brief Title
Concentration of Ertapenem in Colorectal Tissue
Official Title
Konzentrationen Von Ertapenem in Kolorektalem Gewebe
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ulm

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diverticulosis, Colonic, Rectal Neoplasms, Colonic Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ertapenem
Arm Type
Experimental
Arm Description
Administration of 1 gram ertapenem I.V.
Intervention Type
Drug
Intervention Name(s)
Ertapenem
Other Intervention Name(s)
Invanz, EU/1/02/216/001 + /002, ATC code: J01DH03
Intervention Description
powder for infusion, 1 gram I.V., single dose over 30 min.
Primary Outcome Measure Information:
Title
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..
Title
Tissue (Total) Concentrations of Ertapenem in the Colorectal Tissue
Description
The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue every 30 minutes up to 10 hours
Time Frame
The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue as an average of every 30 miuntes up to 10 hours
Secondary Outcome Measure Information:
Title
Safety Assessment
Time Frame
0 to approx. 14 days after admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doris Henne-Bruns, Prof. Dr.
Organizational Affiliation
University of Ulm, Dept. of Visceral Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ulm, Dept. of Visceral Surgery
City
Ulm
ZIP/Postal Code
89075
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
22189340
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.
Results Reference
derived

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Concentration of Ertapenem in Colorectal Tissue

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