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Completed

NCT Number: NCT01407965

Pharmacokinetics of Carbapenem Antibiotics in Obese Patients.

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

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Ulm, Ulm, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

microdialysis catheter

Procedure

Placing of microdialysis catheter in fatty tissue and in the peritoneal cavity

Primary outcomes

  1. Unbound concentration of ertapenem and meropenem in fatty tissue and peritoneal fluid

    Time frame: within 24 h after administration

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 2, 2011
Registry last updated
Oct 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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