Pharmacokinetics of Carbapenem Antibiotics in Obese Patients.

Phase 4

Completed

• Conditions: Obesity
• Interventions: Procedure: microdialysis catheter

• Registration Number: NCT01407965
• Lead Sponsor: University of Ulm

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.

Study Timeline

• Study First Submitted: 2011-07-26
• Study First Submitted QC: 2011-08-01
• Study First Posted: 2011-08-02
• Study Start: 2012-04
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-14
• Last Update Posted: 2016-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Meropenem	microdialysis catheter	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.
Ertapenem	microdialysis catheter	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

Primary Outcome Measures

Name	Time	Method
Unbound concentration of ertapenem and meropenem in fatty tissue and peritoneal fluid	within 24 h after administration

Secondary Outcome Measures

Name	Time	Method
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
Number of Suspected Unexpected Serious Adverse Reactions (SUSARs)	Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Trial Locations

Locations (2)

University of Ulm; 🇩🇪 Ulm, Germany

University of Ulm, Dept. of Visceral Surgery; 🇩🇪 Ulm, Germany