Concentration of Ertapenem in Colorectal Tissue

Rectal Neoplasms Clinical Trial

Official title:

Konzentrationen Von Ertapenem in Kolorektalem Gewebe

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00535652
• Other study ID #: 01-07
• Status: Completed
• Phase: Phase 4
• First received: September 24, 2007
• Last updated: April 5, 2010
• Start date: September 2007
• Est. completion date: December 2009

Study information

• Verified date: February 2009
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 ß-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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonic Neoplasms
• Diverticulosis, Colonic
• Diverticulum
• Neoplasms
• Rectal Neoplasms

Intervention

Drug:
• Ertapenem
powder for infusion, 1 gram I.V., single dose over 30 min.

Locations

Country	Name	City	State
Germany	University of Ulm, Dept. of Visceral Surgery	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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..	No
Secondary	safety assessment		0 to approx. 14 days after admission	Yes