Status:
WITHDRAWN
Penetration of Ertapenem Into Bone
Lead Sponsor:
HaEmek Medical Center, Israel
Conditions:
Amputation
Eligibility:
All Genders
18-75 years
Phase:
NA
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 t...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2007
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00392028
Start Date
November 1 2006
End Date
July 1 2007
Last Update
July 13 2007
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Ha'Emek Medical Center
Afula, Israel, 18101
2
Haemek Medical Center INFECTIOUS DISEASES UNIT
Afula, Israel, 18101
3
Haemek Medical Center INFECTIOUS DISEASES UNIT
Afula, Israel