Clinical Trial: Application of Daptomycin in MRSA Infected Diabetic Foot in Comparison to Vancomycin Treatment
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Application of Daptomycin in MRSA Infected Diabetic Foot in Comparison to Vancomycin Treatment
Brief Summary: Objective of the study is to test whether Daptomycin (6 mg/kg bodyweight) is non-inferior in treatment of severe diabetic foot infections (MRSA) in comparison to antibiotic treatment with Vancomycin (effective blood-plasma concentration of 15 mg/l). In case of microbiologically confirmed gram-negative co-infection effective antibiotic treatment according to microbiologic analysis will be administered upon medical decision in both therapy groups. The study will be carried out as a randomized, open label study.
Detailed Summary:
Sponsor: Ruhr University of Bochum
Current Primary Outcome: Clinical response of the infection at test-of-cure (TOC) at day 14 post therapy [ Time Frame: 14 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Duration of therapy [ Time Frame: 14 days ]time to cure in days is required
- Therapy related complications [ Time Frame: within time frame of 14 days ]
- Number of successful treatments at TOC [ Time Frame: within time frame of 14 days ]
- from the clinician point of view (clinical signs and symptoms)
- from microbiological analysis
- Rate of amputations due to infection [ Time Frame: within time frame of 14 days ]
Original Secondary Outcome: Same as current
Information By: Ruhr University of Bochum
Dates:
Date Received: April 29, 2010
Date Started: July 2011
Date Completion:
Last Updated: May 4, 2015
Last Verified: March 2012
