Concentration of Ertapenem in Colorectal Tissue

• Sponsor: University of Ulm (Other)
• Overall Status: Completed
• CT.gov ID: NCT00535652
• Collaborator: (none)
• Enrollment: 23
• Location: 1
• Arm: 1
• Duration (Months): 27
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diverticulosis, Colonic; Rectal Neoplasms; Colonic Neoplasms	Drug: Ertapenem	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Konzentrationen Von Ertapenem in Kolorektalem Gewebe
• Study Start Date: Sep 1, 2007
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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: Invanz, EU/1/02/216/001 + /002 ATC code: J01DH03

Outcome Measures

Primary Outcome Measures

1. 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..]

2. 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 Outcome Measures

1. Safety Assessment [0 to approx. 14 days after admission]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: M. Wittau, MD, University of Ulm
• ClinicalTrials.gov Identifier: NCT00535652
• Other Study ID Numbers: 01-07
• First Posted: Sep 26, 2007
• Last Update Posted: Feb 10, 2017
• Last Verified: Dec 1, 2016

• Additional relevant MeSH terms: Neoplasms; Rectal Neoplasms; Colonic Neoplasms; Diverticulum; Diverticular Diseases; Diverticulosis, Colonic; Ertapenem

Study Results

Participant Flow

Arm/Group Title	Ertapenem
Arm/Group Description	Administration of 1 gram ertapenem I.V. Ertapenem: powder for infusion, 1 gram I.V., single dose over 30 min.
Period Title: Overall Study
STARTED	23
COMPLETED	20
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Ertapenem
Arm/Group Description	Administration of 1 gram ertapenem I.V. Ertapenem: powder for infusion, 1 gram I.V., single dose over 30 min.
Overall Participants	23
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	19 82.6%
>=65 years	4 17.4%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	55
Gender (Count of Participants)
Female	4 17.4%
Male	19 82.6%
Region of Enrollment (participants) [Number]
Germany	23 100%

Outcome Measures

1. Primary Outcome

Title	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..

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

2. Secondary Outcome

Title	Safety Assessment
Time Frame	0 to approx. 14 days after admission

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ertapenem
Arm/Group Description	Administration of 1 gram ertapenem I.V. Ertapenem: powder for infusion, 1 gram I.V., single dose over 30 min.
Measure Participants	20
Mean (Standard Deviation) [mg/kg]	6.4 (2.3)

Adverse Events

Arm/Group Title	Ertapenem
Arm/Group Description	Administration of 1 gram ertapenem I.V. Ertapenem: powder for infusion, 1 gram I.V., single dose over 30 min.
All Cause Mortality
	Ertapenem
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Ertapenem
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	Ertapenem
	Affected / at Risk (%)	# Events
Total	4/20 (20%)
Renal and urinary disorders
Urinary tract infection	4/20 (20%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.