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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Infusion (6 mg/kg/bodyweight) once daily
vancomycin once daily (effective blood-plasma concentration of 15 mg/L)
Herz- und Diabeteszentrum
Bad Oeynhausen, Germany
Clinical Response of the Infection at Test-of-cure (TOC) at Day 14 Post Therapy
Clinical response of the infection at test-of-cure (TOC) at day 14 post therapy by doctoral's decision For each of the patients included in the study the clinical outcome at TOC should be assessed using the following criteria: Cure: resolution of all clinical signs and symptoms of infection and a healing wound after ≥ 5 days of therapy Improvement: resolution of ≥ 2 - but not all- clinical signs and symptoms of infection after ≥ 5 days of therapy (only used at the end of therapy) Failure: persistence or progression of baseline clinical signs and symptoms of infections after ≥ 2 days of therapy Missing: patients received therapy for less than 2 days Indeterminate: circumstances preclude classification Duration of Treatment The duration of treatment will be evaluated as the number of inpatient and outpatient days the patient received antibiotic therapy, even if non-consecutive. Time to Clinical Improvement If according to the patient record
Time frame: 14 days
Duration of Therapy
Duration of therapy until infection was solved in days
Time frame: 14 days
Therapy Related Complications
Number of therapy related complications
Time frame: within time frame of 14 days
Number of Successful Treatments at TOC
* from the clinician point of view (clinical signs and symptoms) * from microbiological analysis
Time frame: within time frame of 14 days
Rate of Amputations Due to Infection
Rate of amputations due to infection given as number of events per total events in the study in percent
Time frame: within time frame of 14 days
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