Penetration of Ertapenem Into Bone

July 12, 2007 updated by: HaEmek Medical Center, Israel

Penetration of Ertapenem Into Bone in Patients With Diabetes Mellitus or Peripheral Vascular Diseases Who Underwent Bellow Knee Amputation

The aim of the study is to determine the penetration levels of ertapenem into bone tissues in patients with Diabetes Mellitus (D.M) or Peripheral Vascular Diseases (P.V.D) undergoing amputation, and to correlate theme to the concentration of the drug in blood and other soft tissues

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Twelve patients with D.M or P.V.D who are undergoing bellow knee amputation with or without gangrene.

Within four weeks prior the amputation a vascular profile will be determined by Doppler and skin perfusion will be determined by transcutaneous oxygen pressure measurements (TcPO2) on the dorsal side of the mid foot of the affected limb.

Each patient will receive 1 g of Ertapenem in 100 ml of normal saline by IV infusion -during 30 minutes through IVAC:

  • -2 days prior the amputation
  • -1 day prior the amputation
  • 1 hour before amputation The infusions will be started approximately at the same time of the 3rd infusion, prior the planned amputation.

Blood samples (approximately 6ml each) will be collected before Ertapenem administration, simultaneously with bone and soft tissue samples at the time of amputation and at the end of the surgery

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel, 18101
        • Ha'Emek Medical Center
      • Afula, Israel, 18101
        • Haemek Medical Center INFECTIOUS DISEASES UNIT
      • Afula, Israel
        • Haemek Medical Center INFECTIOUS DISEASES UNIT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18
  • Diabetes Mellitus or Peripheral Vascular Disease
  • Undergoing bellow knee amputation with or without gangrene
  • Patients without clinical signs of acute infection
  • Creatinine Clearence more than 60 cc/ min

Exclusion Criteria:

  • Known hypersensitivity to any component of ertapenem or to other drugs in the same class.
  • Patients who have demonstrated anaphylactic reactions to beta-lactams.
  • CNS disorders (e.g., brain lesions or history of seizures).
  • Patient treated with other antibiotics at least 72 hours.
  • Pregnant women, nursing women, or fertile women not practicing adequate methods of contraception.
  • Patient or legal representative of the patient is unable to provide written informed consent for any reason.
  • Patient has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drug to the patient.
  • Neutropenia
  • Renal failure
  • Hepatic Insufficiency: > x 2 upper limit.
  • A need for any additional concomitant systemic antibacterial agent.
  • Life expectancy less than 6 month
  • Patient is undergoing immunosuppressive therapy, including use of high dose corticosteroids (e.g.,20 mg or more prednisone or equivalent per day)
  • Patient is in a situation or has a condition which, in the investigator's opinion, may interfere with optimal participation in the study.
  • Participation in an another clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
blood,tissue and bone drug levels
Time Frame: 3 days each patient
3 days each patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HaEmek Medical Center, Israel

Investigators

  • Study Director: Ruth Kitzes, Clinical Pharmacology Unit, Carmel Medical Center, Haifa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Study Completion (Anticipated)

July 1, 2007

Study Registration Dates

First Submitted

October 24, 2006

First Submitted That Met QC Criteria

October 24, 2006

First Posted (Estimate)

October 25, 2006

Study Record Updates

Last Update Posted (Estimate)

July 13, 2007

Last Update Submitted That Met QC Criteria

July 12, 2007

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • p1101v1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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