Concentration of Ertapenem in Colorectal Tissue
This study has been completed.
Sponsor:
University of Ulm
Information provided by:
University of Ulm
ClinicalTrials.gov Identifier:
NCT00535652
First received: September 24, 2007
Last updated: April 5, 2010
Last verified: February 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diverticulosis, Colonic Rectal Neoplasms Colonic Neoplasms |
Drug: Ertapenem |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Konzentrationen Von Ertapenem in Kolorektalem Gewebe |
Resource links provided by NLM:
Further study details as provided by University of Ulm:
Primary Outcome Measures:
- 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.. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- safety assessment [ Time Frame: 0 to approx. 14 days after admission ] [ Designated as safety issue: Yes ]
| Enrollment: | 23 |
| Study Start Date: | September 2007 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ertapenem
Administration of 1 gram ertapenem I.V.
|
Drug: Ertapenem
powder for infusion, 1 gram I.V., single dose over 30 min.
Other Names:
|
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| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00535652
Locations
| Germany | |
| University of Ulm, Dept. of Visceral Surgery | |
| Ulm, Germany, 89075 | |
Sponsors and Collaborators
University of Ulm
Investigators
| Principal Investigator: | Doris Henne-Bruns, Prof. Dr. | University of Ulm, Dept. of Visceral Surgery |
More Information
No publications provided
| Responsible Party: | Prof. Dr. R. Marre, Universityhospital Ulm |
| ClinicalTrials.gov Identifier: | NCT00535652 History of Changes |
| Other Study ID Numbers: | 01-07 |
| Study First Received: | September 24, 2007 |
| Last Updated: | April 5, 2010 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Neoplasms Colonic Neoplasms Diverticulum Diverticulosis, Colonic Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases |
Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Pathological Conditions, Anatomical Rectal Diseases Ertapenem Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013