NCT00535652

Brief Summary

The purpose of this study is to determine the tissue kinetics of ertapenem in colonic tissue from three hours up to six hours (25% of dosing interval) after administration of ertapenem.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

September 1, 2007

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
7 years until next milestone

Results Posted

Study results publicly available

December 16, 2016

Completed
Last Updated

February 10, 2017

Status Verified

December 1, 2016

Enrollment Period

2.3 years

First QC Date

September 24, 2007

Results QC Date

June 23, 2015

Last Update Submit

December 16, 2016

Conditions

Diverticulosis, ColonicRectal NeoplasmsColonic Neoplasms

Outcome Measures

Primary Outcomes (2)

  • Concentration of Ertapenem in Colorectal Tissue in mg/kg 3 to 6 Hours After a Single Dose of 1 Gram Ertapenem I.V..

    3 to 6 hours after a single dose of 1 gram ertapenem I.V..

  • Tissue (Total) Concentrations of Ertapenem in the Colorectal Tissue

    The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue every 30 minutes up to 10 hours

    The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue as an average of every 30 miuntes up to 10 hours

Secondary Outcomes (1)

  • Safety Assessment

    0 to approx. 14 days after admission

Study Arms (1)

Ertapenem

EXPERIMENTAL

Administration of 1 gram ertapenem I.V.

Drug: Ertapenem

Interventions

ErtapenemDRUG

powder for infusion, 1 gram I.V., single dose over 30 min.

Also known as: Invanz, EU/1/02/216/001 + /002, ATC code: J01DH03
Ertapenem

Eligibility Criteria

Age18 Years - 90 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 the colon will be eligible for this study.
  • Patients with benignant disorders (e.g. colonic diverticulosis) will be preferred.

You may not qualify if:

  • Pregnancy or lactation in women
  • Emergency surgery, history of serious allergy or intolerance to β-lactam antibiotics and other carbapenems
  • 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
  • Chronic immunosuppressive therapy
  • 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 and coagulation studies (INR) \> 1.5 x ULN, ongoing therapy with valproin acid.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ulm, Dept. of Visceral Surgery

Ulm, 89075, Germany

Location

Related Publications (1)

  • Wittau M, Scheele J, Bulitta JB, Mayer B, Kaever V, Burhenne H, Henne-Bruns D, Isenmann R, Brockschmidt C. Pharmacokinetics of ertapenem in colorectal tissue. Chemotherapy. 2011;57(5):437-48. doi: 10.1159/000333377. Epub 2011 Dec 22.

    PMID: 22189340DERIVED

MeSH Terms

Conditions

Diverticulosis, ColonicRectal NeoplasmsColonic Neoplasms

Interventions

Ertapenem

Condition Hierarchy (Ancestors)

Colonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsRectal Diseases

Intervention Hierarchy (Ancestors)

Carbapenemsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Prof. Dr. Henne-Bruns, PI
Organization
University of Ulm
doris.henne-bruns@uniklinik-ulm.de
++4973150053500

Study Officials

  • Doris Henne-Bruns, Prof. Dr.

    University of Ulm, Dept. of Visceral Surgery

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 24, 2007

First Posted

September 26, 2007

Study Start

September 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

February 10, 2017

Results First Posted

December 16, 2016

Record last verified: 2016-12

Locations

DE(1)