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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ertapenem | Experimental | Administration of 1 gram ertapenem I.V. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ertapenem | Drug | powder for infusion, 1 gram I.V., single dose over 30 min. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 every 30 minutes up to 10 hours | The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue as an average of every 30 miuntes up to 10 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Assessment | 0 to approx. 14 days after admission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Doris Henne-Bruns, Prof. Dr. | University of Ulm, Dept. of Visceral Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ulm, Dept. of Visceral Surgery | Ulm | 89075 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22189340 | Derived | Wittau M, Scheele J, Bulitta JB, Mayer B, Kaever V, Burhenne H, Henne-Bruns D, Isenmann R, Brockschmidt C. Pharmacokinetics of ertapenem in colorectal tissue. Chemotherapy. 2011;57(5):437-48. doi: 10.1159/000333377. Epub 2011 Dec 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ertapenem | Administration of 1 gram ertapenem I.V. Ertapenem: powder for infusion, 1 gram I.V., single dose over 30 min. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ertapenem | Administration of 1 gram ertapenem I.V. Ertapenem: powder for infusion, 1 gram I.V., single dose over 30 min. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Concentration of Ertapenem in Colorectal Tissue in mg/kg 3 to 6 Hours After a Single Dose of 1 Gram Ertapenem I.V.. | Not Posted | 3 to 6 hours after a single dose of 1 gram ertapenem I.V.. | Participants | ||||||||||||
| Secondary | Safety Assessment | Not Posted | 0 to approx. 14 days after admission | Participants |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ertapenem | Administration of 1 gram ertapenem I.V. Ertapenem: powder for infusion, 1 gram I.V., single dose over 30 min. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Henne-Bruns, PI | University of Ulm | ++4973150053500 | doris.henne-bruns@uniklinik-ulm.de |
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| ID | Term |
|---|---|
| D043963 | Diverticulosis, Colonic |
| D012004 | Rectal Neoplasms |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000077727 | Ertapenem |
| ID | Term |
|---|---|
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Primary | Tissue (Total) Concentrations of Ertapenem in the Colorectal Tissue | The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue every 30 minutes up to 10 hours | Posted | Mean | Standard Deviation | mg/kg | The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue as an average of every 30 miuntes up to 10 hours |
|
|
|
| 0 |
| 20 |
| 4 |
| 20 |
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| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012002 | Rectal Diseases |
| Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |