Penetration of Ertapenem Into Bone

Sponsor

HaEmek Medical Center, Israel (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00392028

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Nov 1, 2006

Anticipated Study Completion Date :

Jul 1, 2007

Outcome Measures

Primary Outcome Measures

blood,tissue and bone drug levels [3 days each patient]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
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