Status:
COMPLETED
Target Site Pharmacokinetics of Ertapenem After Multiple Doses in Diabetes Patients With Soft Tissue Infection
Lead Sponsor:
Medical University of Vienna
Conditions:
Soft Tissue Infection
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
Background/rationale: Ertapenem is an innovative antimicrobial agent, which is approved in the European Union for diabetic foot infections of the skin and soft tissue. Although its antimicrobial spect...
Eligibility Criteria
Inclusion
- Male or female, aged between 18 and 85 years
- Diagnosis of Diabetes mellitus
- Clinically diagnosed skin or soft tissue infection and/or infected ulcers of the leg, requiring antimicrobial therapy
- Prescription of ertapenem for therapeutic reasons
- Willingness and ability to comply with the protocol
- Signed informed consent
Exclusion
- HIV, Hepatitis B or C positive
- Allergy or hypersensitivity against study drug
- Severe renal impairment, defined by a serum creatinine level \> 1.6 mg/L
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00658866
Start Date
February 1 2008
End Date
February 1 2011
Last Update
August 9 2011
Active Locations (1)
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1
Medical University Vienna, Department of Clinical Pharacology
Vienna, Vienna, Austria, 1090