Penetration of Ertapenem Into Bone

This study has been withdrawn prior to enrollment.
(no recruitment)
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00392028
First received: October 24, 2006
Last updated: July 12, 2007
Last verified: July 2007
  Purpose

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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00392028

Locations
Israel
Haemek Medical Center INFECTIOUS DISEASES UNIT
Afula, Israel
Haemek Medical Center INFECTIOUS DISEASES UNIT
Afula, Israel, 18101
Ha'Emek Medical Center
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Study Director: Ruth Kitzes Clinical Pharmacology Unit, Carmel Medical Center, Haifa
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00392028     History of Changes
Other Study ID Numbers: p1101v1
Study First Received: October 24, 2006
Last Updated: July 12, 2007
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Peripheral Vascular Diseases
Peripheral Arterial Disease
Vascular Diseases
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Ertapenem
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014