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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetic Foot

Intervention / Treatment
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* Drug: Daptomycin
* Drug: Vancomycin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 and Type 2 Diabetes mellitus MRSA infected foot ulcus Wagner 1-2 without primary surgical intervention Therapy duration will last at least more than 5 days men and women age 18 - 80 years Declaration of patient's consent Ability and willingness to give written informed consent and to comply with the requirements of the study Sexually active females, unless surgically sterile, must be willing to use 2 forms of contraception through the end of the study. Sexually active woman must, except if they were surgically sterilized, have to use for already 30 days before first dose of study medication an effective method of pregnancy prevention. Acceptable forms of contraception for female subjects include: oral, transdermal, injectable or implanted contraceptives, intrauterine device (IUD), female condom, diaphragm with spermicide, cervical cap, absolute waiver of sexual intercourse, use of a condom by the sexual partner, or sterile sexual partner. Male subjects with partners of child-bearing potential should use barrier contraception in addition to having their partners use another method of contraception. Exclusion Criteria: Osteomyelitis according to international consensus guideline (3 of 5 criteria apply for diagnosis) Presence of a severe nephropathy (creatinine clearance < 30 ml/min) Advanced diabetic retinopathy Simultaneous participation in another study or participation in a study in the past 30 days Non permissible concomitant medication e.g. therapy regimen using several antibiotics Contraindication for antibiotics Dialysis essential Pregnancy (to be determined by pregnancy test) or unsafe contraception Neutropenia immunosuppression (oral immunosuppressives, Corticoids exaggerating 7.5 mg Prednisolon-equivalents) Chronic liver disease (AST or ALT increased to 10fold, bilirubin increased to threefold compared to normal values)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daptomycin<br>Infusion of Daptomycin (6 mg/kg bodyweight) once daily | Drug: Daptomycin<br>* Infusion (6 mg/kg/bodyweight) once daily<br>* Other names: Cubicin;|
| Active Comparator: Vancomycin<br>Vancomycin once daily (effective blood-plasma concentration of 15 mg/l) | Drug: Vancomycin<br>* vancomycin once daily (effective blood-plasma concentration of 15 mg/L)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response of the infection at test-of-cure (TOC) at day 14 post therapy |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of therapy | time to cure in days is required | 14 days | 
| Therapy related complications |  | 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 | within time frame of 14 days | 
| Rate of amputations due to infection |  | within time frame of 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Foot,MRSA,, Complicated skin and skin structure infections, Antimicrobial therapy, Daptomycin