Penetration of Ertapenem Into Bone

HaEmek Medical Center, Israel

Status

Withdrawn

Conditions

Amputation

Treatments

Drug: ertapenem

Study type

Interventional

Funder types

Other

Identifiers

NCT00392028

p1101v1

Details and patient eligibility

About

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

Full 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

Enrollment

12 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.