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Penetration of Ertapenem Into Bone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00392028
Recruitment Status : Withdrawn (no recruitment)
First Posted : October 25, 2006
Last Update Posted : July 13, 2007
Information provided by:
HaEmek Medical Center, Israel

Brief Summary:
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 or disease Intervention/treatment Phase
Amputation Drug: ertapenem Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
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
Study Start Date : November 2006
Estimated Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00392028

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Ha'Emek Medical Center
Afula, Israel, 18101
Afula, Israel, 18101
Afula, Israel
Sponsors and Collaborators
HaEmek Medical Center, Israel
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Study Director: Ruth Kitzes Clinical Pharmacology Unit, Carmel Medical Center, Haifa
Layout table for additonal information Identifier: NCT00392028    
Other Study ID Numbers: p1101v1
First Posted: October 25, 2006    Key Record Dates
Last Update Posted: July 13, 2007
Last Verified: July 2007
Keywords provided by HaEmek Medical Center, Israel:
Bone drug level
Blood drug level
Tissue drug level
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Anti-Infective Agents