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Pharmacokinetics of Carbapenem Antibiotics in Obese Patients.

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ClinicalTrials.gov Identifier: NCT01407965
Recruitment Status : Completed
First Posted : August 2, 2011
Last Update Posted : October 17, 2016
Sponsor:
Information provided by (Responsible Party):
M. Wittau, University of Ulm

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

Condition or disease Intervention/treatment Phase
Obesity Procedure: microdialysis catheter Phase 4

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  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : April 2012
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Unbound concentration of ertapenem and meropenem in fatty tissue and peritoneal fluid [ Time Frame: within 24 h after administration ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01407965


Locations
Germany
University of Ulm, Dept. of Visceral Surgery
Ulm, Germany, 89075
University of Ulm
Ulm, Germany, 89075
Sponsors and Collaborators
University of Ulm
Investigators
Principal Investigator: Doris Henne-Bruns, PhD University of Ulm
Principal Investigator: Mathias Wittau, Dr. University of Ulm