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Concentration of Ertapenem in Colorectal Tissue

Information source: University of Ulm
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diverticulosis, Colonic; Rectal Neoplasms; Colonic Neoplasms

Intervention: Ertapenem (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Ulm

Official(s) and/or principal investigator(s):
Doris Henne-Bruns, Prof. Dr., Principal Investigator, Affiliation: University of Ulm, Dept. of Visceral Surgery

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.

Clinical Details

Official title: Konzentrationen Von Ertapenem in Kolorektalem Gewebe

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

Primary outcome: Concentration of ertapenem in colorectal tissue in mg/kg 3 to 6 hours after a single dose of 1 gram ertapenem I.V..

Secondary outcome: safety assessment

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.

Eligibility

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

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.

Locations and Contacts

University of Ulm, Dept. of Visceral Surgery, Ulm 89075, Germany
Additional Information

Starting date: September 2007
Last updated: April 5, 2010

Page last updated: August 23, 2015

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