Pharmacokinetics of Carbapenem Antibiotics in Obese Patients.
Information source: University of Ulm
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity
Intervention: microdialysis catheter (Procedure); microdialysis catheter (Procedure)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Ulm Official(s) and/or principal investigator(s):
Doris Henne-Bruns, PhD, Principal Investigator, Affiliation: University of Ulm
Mathias Wittau, Dr., Principal Investigator, Affiliation: University of Ulm
Overall contact:
Doris Henne-Bruns, PhD, Phone: (0)73150053500, Ext: +49, Email: doris.henne-bruns@uniklinik-ulm.de
Summary
Tissue kinetics of ertapenem and meropenem in fatty tissue, intraperitoneal fluid and
plasma.
Clinical Details
Official title: Offene, Monozentrische, Nicht Kontrollierte Und Nicht Randomisierte Phase IV-Studie Zur Bestimmung Der Pharmakokinetik Von Carbapenemen in adipösen Patienten.
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Unbound concentration of ertapenem and meropenem in fatty tissue and peritoneal fluid
Secondary outcome: Number of Adverse Events (total and per patient)Number of Serious Adverse Events (total and per patient) Number of Suspected Unexpected Serious Adverse Reactions (SUSARs)
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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).
Locations and Contacts
Doris Henne-Bruns, PhD, Phone: (0)73150053500, Ext: +49, Email: doris.henne-bruns@uniklinik-ulm.de
University of Ulm, Ulm 89075, Germany; Recruiting
Doris Henne-Bruns, PhD., Phone: +(49)73150053500, Email: doris.henne-bruns@uniklinik-ulm.de
Mathias Wittau, MD, Phone: +(49)73150053500, Email: mathias.wittau@uniklinik-ulm.de
Doris Henne-Bruns, MD, PhD, Principal Investigator
University of Ulm, Dept. of Visceral Surgery, Ulm 89075, Germany; Recruiting
Doris Henne-Bruns, Prof. Dr., Phone: +49(0)73150053500, Email: doris.henne-bruns@uniklinik-ulm.de
Mathias Wittau, Dr., Phone: +49(0)73150053500, Email: mathias.wittau@uniklinik-ulm.de
Additional Information
Starting date: April 2012
Last updated: June 8, 2015
|
