Target site pharmacokinetics of linezolid after repetitive doses in diabetic patients with bacterial foot infectio

Phase 1

Conditions: The study population will consist of a representative group of adult male or female patients with documented diabetes and bacterial soft tissue infection of the foot complicated by osteomyelitis. Patients must be subjected to undergo surgical debridement and intravenous antimicrobial therapy.

Registration Number: EUCTR2008-006153-41-AT

Lead Sponsor: Medical university Graz, Department of Plastic Surgery

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Written informed consent to participate in the study
2. Male or female patient of 18 years of age or older
3. Patient suffers from documented diabetes and soft tissue infection of the lower limb complicated by osteomyelitis
4. Patient requires surgical debridement with bone resection and intravenous anti-microbial therapy
5. Negative urine pregnancy test in females of childbearing potential
6. Patient is willing to participate in the study, follow protocol study treatment regimen, and comply with all planned assessments.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Treatment with the study drug within the past three weeks prior to study enrolment.
2. Relevant renal dysfunction indicated by a creatinine clearance = 40 ml/min as determined by the Cockcroft-Gault equation using actual body weight (Appendix 4).
3. Severe hepatic impairment defined by a serum AST = 150.
4. Neutrophil count <1000/µl
5. Thrombocytopenia < 50 000 /µl
6. HIV, HCV or HBV infection.
7. History of hypersensitivity to the study drug or to drugs with similar chemical structures (oxazolidinones).
8. Treatment with antidepressants belonging to the class of selective serotonin reuptake inhibitors (SSRIs) and selective serotonin and noradrenalin reuptake inhibitors (SNRIs)
9. Patients submitted to the hospital with known pathogens resistant to study drug
10. Use of any other investigational therapy at the time of enrolment, or within 30 days.
11. Patients unable or unwilling to adhere to the study-designated procedures and restrictions.
12. Unable to understand the nature, purpose and extent of the study
13. Breast-feeding woman

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the pharmacokinetic profile of linezolid in inflamed subcutaneous adipose tissue in diabetic foot infection at steady state after twice daily intravenous administration of 600 mg.;Secondary Objective: - To evaluate the pharmacokinetic profiles of linezolid in non-inflamed subcutaneous adipose tissue, bone and plasma<br><br>- To compare the pharmacokinetic profiles of inflamed soft tissue, healthy soft tissue, bone and plasma;Primary end point(s):

Secondary Outcome Measures