Target site pharmacokinetics of linezolid after single and multiple doses in diabetes patients with soft tissue infectio
- Conditions
- diabetic patients with soft tissue infection, necessiting antibiotic therapy
- Registration Number
- EUCTR2007-007958-54-AT
- Lead Sponsor
- Department of Clinical Pharmacology, Medical University of Vienna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
•Male or female, = 18 years old
•Diagnosis of Diabetes mellitus
•Clinically diagnosed skin or STI and/or infected ulcers of the leg, requiring antimicrobial therapy
•Prescription of antibiotic indicated, with Linezolid being an adequate therapy.
•Willingness and ability to comply with the protocol
•Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
•Allergy or hypersensitivity against study drug.
•Severe renal impairment, defined by a serum creatinine level > 1.6 mg/L
•Severe hepatic impairment ( Child-Pugh Class C)
•Pregnancy, or women of child bearing potential not willing to apply adequate contraception during study period
•Any disease considered relevant for proper performance of the study or risks to the patient, at the discretion of the investigator
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
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