Pharmacokinetics of Carbapenem Antibiotics in Obese Patients.
NCT ID: NCT01407965
Last Updated: 2016-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
13 participants
INTERVENTIONAL
2012-04-30
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Ertapenem
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
microdialysis catheter
Placing of microdialysis catheter in fatty tissue and in the peritoneal cavity
Meropenem
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.
microdialysis catheter
Placing of microdialysis catheter in fatty tissue and in the peritoneal cavity
Interventions
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microdialysis catheter
Placing of microdialysis catheter in fatty tissue and in the peritoneal cavity
microdialysis catheter
Placing of microdialysis catheter in fatty tissue and in the peritoneal cavity
Eligibility Criteria
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Inclusion Criteria
* BMI more or even 40
* written informed consent
Exclusion Criteria
* pregnancy or lactation in women
* emergency surgery
* history of serious allergy or intolerance to β-lactam antibiotics
* 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
* 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
* coagulation studies (INR) \> 1.5 x ULN
* ongoing chemotherapy and/or radiotherapy
* ongoing therapy with valproin acid (in case of ertapenem administration).
18 Years
ALL
No
Sponsors
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University of Ulm
OTHER
Responsible Party
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M. Wittau
MD
Principal Investigators
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Doris Henne-Bruns, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Ulm
Mathias Wittau, Dr.
Role: PRINCIPAL_INVESTIGATOR
University of Ulm
Locations
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University of Ulm, Dept. of Visceral Surgery
Ulm, , Germany
University of Ulm
Ulm, , Germany
Countries
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References
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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.
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.
Other Identifiers
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2010-024094-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Adip-2010
Identifier Type: -
Identifier Source: org_study_id
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