NCT01407965

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_4 obesity

Timeline
Completed

Started Apr 2012

Typical duration for phase_4 obesity

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 2, 2011

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

October 17, 2016

Status Verified

October 1, 2016

Enrollment Period

3.2 years

First QC Date

July 26, 2011

Last Update Submit

October 14, 2016

Conditions

Obesity

Keywords

obesitypharmacokineticertapenemmeropenem

Outcome Measures

Primary Outcomes (1)

  • Unbound concentration of ertapenem and meropenem in fatty tissue and peritoneal fluid

    within 24 h after administration

Secondary Outcomes (3)

  • Number of Adverse Events (total and per patient)

    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)

    Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

  • Number of Suspected Unexpected Serious Adverse Reactions (SUSARs)

    Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Study Arms (2)

Ertapenem

EXPERIMENTAL

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

Meropenem

EXPERIMENTAL

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

Interventions

microdialysis catheterPROCEDURE

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

Ertapenem

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Ulm, Dept. of Visceral Surgery

Ulm, 89075, Germany

Location

University of Ulm

Ulm, 89075, Germany

Location

Related Publications (2)

  • Wittau M, Paschke S, Kurlbaum M, Scheele J, Ly NS, Hemper E, Kornmann M, Henne-Bruns D, Bulitta JB. Population Pharmacokinetics and Target Attainment of Ertapenem in Plasma and Tissue Assessed via Microdialysis in Morbidly Obese Patients after Laparoscopic Visceral Surgery. Antimicrob Agents Chemother. 2016 Dec 27;61(1):e00952-16. doi: 10.1128/AAC.00952-16. Print 2017 Jan.

    PMID: 27795367DERIVED

  • Wittau M, Scheele J, Kurlbaum M, Brockschmidt C, Wolf AM, Hemper E, Henne-Bruns D, Bulitta JB. Population Pharmacokinetics and Target Attainment of Meropenem in Plasma and Tissue of Morbidly Obese Patients after Laparoscopic Intraperitoneal Surgery. Antimicrob Agents Chemother. 2015 Oct;59(10):6241-7. doi: 10.1128/AAC.00259-15. Epub 2015 Jul 27.

    PMID: 26248353DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Doris Henne-Bruns, PhD

    University of Ulm

    PRINCIPAL INVESTIGATOR

  • Mathias Wittau, Dr.

    University of Ulm

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 26, 2011

First Posted

August 2, 2011

Study Start

April 1, 2012

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

October 17, 2016

Record last verified: 2016-10

Locations

DE(2)