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Pharmacokinetics of Carbapenem Antibiotics in Obese Patients.

This study is currently recruiting participants.
Verified April 2012 by University of Ulm
Sponsor:
Information provided by (Responsible Party):
M. Wittau, University of Ulm
ClinicalTrials.gov Identifier:
NCT01407965
First received: July 26, 2011
Last updated: April 20, 2012
Last verified: April 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Obesity
 Procedure: microdialysis catheter
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Offene, Monozentrische, Nicht Kontrollierte Und Nicht Randomisierte Phase IV-Studie Zur Bestimmung Der Pharmakokinetik Von Carbapenemen in adipösen Patienten.

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Obesity
U.S. FDA Resources

Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • Unbound concentration of ertapenem and meropenem in fatty tissue and peritoneal fluid [ Time Frame: within 24 h after administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: April 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01407965

Contacts
Contact: Doris Henne-Bruns, PhD (0)73150053500 ext +49 doris.henne-bruns@uniklinik-ulm.de

Locations
Germany
University of Ulm, Dept. of Visceral Surgery Recruiting
Ulm, Germany, 89075
Contact: Doris Henne-Bruns, Prof. Dr.     +49(0)73150053500     doris.henne-bruns@uniklinik-ulm.de    
Contact: Mathias Wittau, Dr.     +49(0)73150053500     mathias.wittau@uniklinik-ulm.de    
University of Ulm Recruiting
Ulm, Germany, 89075
Contact: Doris Henne-Bruns, PhD.     +(49)73150053500     doris.henne-bruns@uniklinik-ulm.de    
Contact: Mathias Wittau, MD     +(49)73150053500     mathias.wittau@uniklinik-ulm.de    
Principal Investigator: Doris Henne-Bruns, MD, PhD            
Sponsors and Collaborators
University of Ulm
Investigators
Principal Investigator: Doris Henne-Bruns, PhD University of Ulm
Principal Investigator: Mathias Wittau, Dr. University of Ulm
  More Information

No publications provided

Responsible Party: M. Wittau, MD, University of Ulm
ClinicalTrials.gov Identifier: NCT01407965     History of Changes
Other Study ID Numbers: Adip-2010, 2010-024094-39
Study First Received: July 26, 2011
Last Updated: April 20, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Ulm:
obesity
pharmacokinetic
ertapenem
meropenem

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
 Meropenem
Ertapenem
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013