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
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