NCT01199783

Application of Daptomycin in MRSA Infected Diabetic Foot in Comparison to Vancomycin Treatment

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Ruhr University of Bochum · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Foot

Interventions

Type	Name	Description
DRUG	Daptomycin	Infusion (6 mg/kg/bodyweight) once daily
DRUG	Vancomycin	vancomycin once daily (effective blood-plasma concentration of 15 mg/L)

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-10-01
• Completion: 2013-12-01
• First posted: 2010-09-13
• Last updated: 2024-03-18
• Results posted: 2024-03-18

Locations

1 site across 1 country: Germany