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. Subjects are patients. Hospitalized patients 18 years or older requiring elective surgical intervention (open or laparoscopic surgery) at intraabdominal organs with a BMI >= 40 will be eligible for this study.
Conditions
Interventions
Trade Name: Invanz
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: ERTAPENEM SODIUM
CAS Number: 153773-82-1
Concentration unit: mg milligram(s)
Concentration typ
Sponsors
University of Ulm, University Hospital Ulm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Hospitalized patients 18 years or older requiring elective surgical intervention (open or laparoscopic surgery) at intraabdominal organs will be eligible for this study. 2 x 6 patients with a BMI more or even 40 requiring abdominal surgery will be enrolled in this study after written informed consent. Conventional therapies will not be changed during the study period. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: BMI 6 x upper limit of normal (ULN) and bilirubin > 3 x ULN, severe renal insufficiency with a creatinine clearance =30 mL/min., neutrophil count 1.5 x ULN. Ongoing chemotherapy and/or radiotherapy. Ongoing therapy with valproin acid (in case of ertapenem administration).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. Subjects are patients. Hospitalized patients 18 years or older requiring elective surgical intervention (open or laparoscopic surgery) at intraabdominal organs with a BMI >= 40 will be eligible for this study. Further, the free and bound plasma concentration of the IMPs will be determined.;Secondary Objective: Frequency of adverse effects, serious adverse effects and SUSARs after administration of the drugs;Primary end point(s): Free tissue kinetics of ertapenem and meropenem in fatty tissue and intraperitoneal fluid in mg/L up to 24 hours after administration of ertapenem or meropenem. Free and bound plasma concentration of ertapenem or meropenem in mg/L. | — |
Countries
Germany
Outcome results
None listed