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Completed

NCT Number: NCT00535652

Concentration of Ertapenem in Colorectal Tissue

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Ulm, Dept. of Visceral Surgery

Ulm, 89075, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ertapenem

Drug

powder for infusion, 1 gram I.V., single dose over 30 min.

Other names: Invanz, EU/1/02/216/001 + /002, ATC code: J01DH03

Primary outcomes

  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 outcomes

  1. Safety Assessment

    Time frame: 0 to approx. 14 days after admission

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Registry information

Official study title

Konzentrationen Von Ertapenem in Kolorektalem Gewebe

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Sep 26, 2007
Registry last updated
Feb 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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