Penetration of Ertapenem Into Bone

• Status: Withdrawn
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HaEmek Medical Center, Israel
• Treatments: Ertapenem

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.