Penetration of Ertapenem Into Bone
Information source: HaEmek Medical Center, Israel
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Amputation
Intervention: ertapenem (Drug)
Phase: N/A
Status: Withdrawn
Sponsored by: HaEmek Medical Center, Israel Official(s) and/or principal investigator(s):
Ruth Kitzes, Study Director, Affiliation: Clinical Pharmacology Unit, Carmel Medical Center, Haifa
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
Clinical Details
Official title: Penetration of Ertapenem Into Bone in Patients With Diabetes Mellitus or Peripheral Vascular Diseases Who Underwent Bellow Knee Amputation
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: blood,tissue and bone drug levels
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
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
Ha'Emek Medical Center, Afula 18101, Israel
Haemek Medical Center INFECTIOUS DISEASES UNIT, Afula 18101, Israel
Haemek Medical Center INFECTIOUS DISEASES UNIT, Afula, Israel
Additional Information
Starting date: November 2006
Last updated: July 12, 2007
|
