Concentration of Ertapenem in Colorectal Tissue

Konzentrationen Von Ertapenem in Kolorektalem Gewebe

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00535652

Enrollment

Registered

2007-09-26

Start date

2007-09-30

Completion date

2009-12-31

Last updated

2017-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Neoplasms, Diverticulosis, Colonic, Rectal Neoplasms

Brief 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.

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.

Interventions

DRUGErtapenem

powder for infusion, 1 gram I.V., single dose over 30 min.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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..	—
Tissue (Total) Concentrations of Ertapenem in the Colorectal Tissue	The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue as an average of every 30 miuntes up to 10 hours	The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue every 30 minutes up to 10 hours

Secondary

Measure	Time frame
Safety Assessment	0 to approx. 14 days after admission

Countries

Germany

Participant flow

Participants by arm

Arm	Count
Ertapenem Administration of 1 gram ertapenem I.V. Ertapenem: powder for infusion, 1 gram I.V., single dose over 30 min.	23
Total	23

Baseline characteristics

Characteristic	Ertapenem
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	4 Participants
Age, Categorical Between 18 and 65 years	19 Participants
Age, Continuous	55 years
Gender Female	4 Participants
Gender Male	19 Participants
Region of Enrollment Germany	23 participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	4 / 20
serious Total, serious adverse events	0 / 20

Outcome results

Primary