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Penetration of Ertapenem Into Bone

This study has been withdrawn prior to enrollment.
(no recruitment)
Information provided by:
HaEmek Medical Center, Israel Identifier:
First received: October 24, 2006
Last updated: July 12, 2007
Last verified: July 2007
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

Condition Intervention
Amputation Drug: ertapenem

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Penetration of Ertapenem Into Bone in Patients With Diabetes Mellitus or Peripheral Vascular Diseases Who Underwent Bellow Knee Amputation

Resource links provided by NLM:

Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • blood,tissue and bone drug levels [ Time Frame: 3 days each patient ]

Estimated Enrollment: 12
Study Start Date: November 2006
Estimated Study Completion Date: July 2007
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


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00392028

Ha'Emek Medical Center
Afula, Israel, 18101
Afula, Israel, 18101
Afula, Israel
Sponsors and Collaborators
HaEmek Medical Center, Israel
Study Director: Ruth Kitzes Clinical Pharmacology Unit, Carmel Medical Center, Haifa
  More Information Identifier: NCT00392028     History of Changes
Other Study ID Numbers: p1101v1
Study First Received: October 24, 2006
Last Updated: July 12, 2007

Keywords provided by HaEmek Medical Center, Israel:
Bone drug level
Blood drug level
Tissue drug level

Additional relevant MeSH terms:
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Anti-Bacterial Agents
Anti-Infective Agents processed this record on August 23, 2017