Status:
COMPLETED
Pharmacokinetics of Carbapenem Antibiotics in Obese Patients.
Lead Sponsor:
University of Ulm
Conditions:
Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Tissue kinetics of ertapenem and meropenem in fatty tissue, intraperitoneal fluid and plasma.
Detailed Description
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.
Eligibility Criteria
Inclusion
- Hospitalized patients 18 years or older requiring elective surgical intervention (open or laparoscopic surgery) at intraabdominal organs
- BMI more or even 40
- written informed consent
Exclusion
- BMI \< 40
- 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).
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01407965
Start Date
April 1 2012
End Date
July 1 2015
Last Update
October 17 2016
Active Locations (2)
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1
University of Ulm, Dept. of Visceral Surgery
Ulm, Germany, 89075
2
University of Ulm
Ulm, Germany, 89075