Concentration of Ertapenem in Colorectal Tissue

Phase 4

Completed

• Conditions: Diverticulosis, Colonic; Rectal Neoplasms; Colonic Neoplasms
• Interventions: Drug: Ertapenem

• Registration Number: NCT00535652
• Lead Sponsor: University of Ulm

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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-24
• Study First Submitted QC: 2007-09-24
• Study First Posted: 2007-09-26
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Results First Submitted: 2015-06-23
• Results First Submitted QC: 2016-10-24
• Status Verified: 2016-12
• Results First Posted: 2016-12-16
• Last Update Submitted: 2016-12-16
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ertapenem	Ertapenem	Administration of 1 gram ertapenem I.V.

Primary Outcome Measures

Name	Time	Method
Concentration of Ertapenem in Colorectal Tissue in mg/kg 3 to 6 Hours After a Single Dose of 1 Gram Ertapenem I.V..	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 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

Name	Time	Method
Safety Assessment	0 to approx. 14 days after admission

Trial Locations

Locations (1)

University of Ulm, Dept. of Visceral Surgery; 🇩🇪 Ulm, Germany