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Konzentrationen Von Ertapenem in Kolorektalem Gewebe


Phase 4
18 Years
90 Years
Not Enrolling
Both
Diverticulosis, Colonic, Rectal Neoplasms, Colonic Neoplasms

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Trial Information

Konzentrationen Von Ertapenem in Kolorektalem Gewebe


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

3 to 6 hours after a single dose of 1 gram ertapenem I.V..

Safety Issue:

No

Principal Investigator

Doris Henne-Bruns, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Ulm, Dept. of Visceral Surgery

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

01-07

NCT ID:

NCT00535652

Start Date:

September 2007

Completion Date:

December 2009

Related Keywords:

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

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