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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024094-39 | EudraCT Number |
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Tissue kinetics of ertapenem and meropenem in fatty tissue, intraperitoneal fluid and plasma.
The purpose of this study is to determine the free tissue kinetics of ertapenem and meropenem in fatty tissue and intraperitoneal fluid up to 24 hours after administration of the IMP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ertapenem | Experimental | Free tissue kinetics of ertapenem in fatty tissue and intraperitoneal fluid in mg/L Free and bound plasma concentration of ertapenem or meropenem in mg/L |
|
| Meropenem | Experimental | Free tissue kinetics of meropenem in fatty tissue and intraperitoneal fluid in mg/L up to 24 hours after administration. Free and bound plasma concentration of meropenem in mg/L. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| microdialysis catheter | Procedure | Placing of microdialysis catheter in fatty tissue and in the peritoneal cavity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Unbound concentration of ertapenem and meropenem in fatty tissue and peritoneal fluid | within 24 h after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events (total and per patient) | Participants will be followed for the duration of hospital stay, an expected average of 3 weeks | |
| Number of Serious Adverse Events (total and per patient) | Participants will be followed for the duration of hospital stay, an expected average of 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Doris Henne-Bruns, PhD | University of Ulm | Principal Investigator |
| Mathias Wittau, Dr. | University of Ulm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ulm, Dept. of Visceral Surgery | Ulm | 89075 | Germany | |||
| University of Ulm |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27795367 | Derived | Wittau M, Paschke S, Kurlbaum M, Scheele J, Ly NS, Hemper E, Kornmann M, Henne-Bruns D, Bulitta JB. Population Pharmacokinetics and Target Attainment of Ertapenem in Plasma and Tissue Assessed via Microdialysis in Morbidly Obese Patients after Laparoscopic Visceral Surgery. Antimicrob Agents Chemother. 2016 Dec 27;61(1):e00952-16. doi: 10.1128/AAC.00952-16. Print 2017 Jan. | |
| 26248353 |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| microdialysis catheter | Procedure | Placing of microdialysis catheter in fatty tissue and in the peritoneal cavity |
|
| Number of Suspected Unexpected Serious Adverse Reactions (SUSARs) | Participants will be followed for the duration of hospital stay, an expected average of 3 weeks |
| Ulm |
| 89075 |
| Germany |
| Derived |
| Wittau M, Scheele J, Kurlbaum M, Brockschmidt C, Wolf AM, Hemper E, Henne-Bruns D, Bulitta JB. Population Pharmacokinetics and Target Attainment of Meropenem in Plasma and Tissue of Morbidly Obese Patients after Laparoscopic Intraperitoneal Surgery. Antimicrob Agents Chemother. 2015 Oct;59(10):6241-7. doi: 10.1128/AAC.00259-15. Epub 2015 Jul 27. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |