Clinical trial NCT01407965: Pharmacokinetics of Carbapenem Antibiotics in Obese Patients.
Official title: Offene, Monozentrische, Nicht Kontrollierte Und Nicht Randomisierte Phase IV-Studie Zur Bestimmung Der Pharmakokinetik Von Carbapenemen in adipösen Patienten.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Keywords: obesity
pharmacokinetic
ertapenem
meropenem
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2011-08-02
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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 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).

Primary outcomes:
measure: Unbound concentration of ertapenem and meropenem in fatty tissue and peritoneal fluid
timeFrame: within 24 h after administration
Secondary outcomes:
measure: Number of Adverse Events (total and per patient)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
measure: Number of Serious Adverse Events (total and per patient)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
measure: Number of Suspected Unexpected Serious Adverse Reactions (SUSARs)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: University of Ulm, Dept. of Visceral Surgery
city: Ulm
country: Germany
facility: University of Ulm
Study officials:
affiliation: University of Ulm
name: Doris Henne-Bruns, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ulm
name: Mathias Wittau, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.