Clinical trial NCT00392028: Penetration of Ertapenem Into Bone
Official title: Penetration of Ertapenem Into Bone in Patients With Diabetes Mellitus or Peripheral Vascular Diseases Who Underwent Bellow Knee Amputation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Amputation
Keywords: Ertapenem
Bone drug level
Blood drug level
Tissue drug level
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2006-10-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: blood,tissue and bone drug levels
timeFrame: 3 days each patient
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Ha'Emek Medical Center
city: Afula
country: Israel
facility: Haemek Medical Center INFECTIOUS DISEASES UNIT
city: Afula
country: Israel
facility: Haemek Medical Center INFECTIOUS DISEASES UNIT
Study officials:
affiliation: Clinical Pharmacology Unit, Carmel Medical Center, Haifa
name: Ruth Kitzes
role: STUDY_DIRECTOR
References: