Pharmacokinetics of Carbapenem Antibiotics in Obese Patients.

October 14, 2016 updated by: M. Wittau, University of Ulm

Offene, Monozentrische, Nicht Kontrollierte Und Nicht Randomisierte Phase IV-Studie Zur Bestimmung Der Pharmakokinetik Von Carbapenemen in adipösen Patienten.

Tissue kinetics of ertapenem and meropenem in fatty tissue, intraperitoneal fluid and plasma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Ulm, Germany, 89075
        • University of Ulm, Dept. of Visceral Surgery
      • Ulm, Germany, 89075
        • University of Ulm

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Procedure: microdialysis catheter
Placing of microdialysis catheter in fatty tissue and in the peritoneal cavity
Experimental: 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.
Procedure: microdialysis catheter
Placing of microdialysis catheter in fatty tissue and in the peritoneal cavity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Unbound concentration of ertapenem and meropenem in fatty tissue and peritoneal fluid
Time Frame: within 24 h after administration
within 24 h after administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Adverse Events (total and per patient)
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
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)
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Number of Suspected Unexpected Serious Adverse Reactions (SUSARs)
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulm

Investigators

  • Principal Investigator: Doris Henne-Bruns, PhD, University of Ulm
  • Principal Investigator: Mathias Wittau, Dr., University of Ulm

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

July 26, 2011

First Submitted That Met QC Criteria

August 1, 2011

First Posted (Estimate)

August 2, 2011

Study Record Updates

Last Update Posted (Estimate)

October 17, 2016

Last Update Submitted That Met QC Criteria

October 14, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Adip-2010
  • 2010-024094-39 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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