Application of Daptomycin in MRSA infected diabetic foot in comparison to vancomycin treatment

Heart- and Diabetescenter NRW0 个研究点开始时间: 2010年9月23日最近更新: 2012年5月15日

适应症

试验速览

暂无简介。

•Type 1 and Type 2 Diabetes mellitus
•MRSA infected foot ulcus Wagner 1-2 without primary surgical intervention
•Therapy duration > 5 days
•men and women = 18 – 80 years old
•Declaration of patient’s consent
•Ability and willingness to give written informed consent and to comply with the requirements of the study
•patients should use an effective method of pregnancy prevention through the end of the study
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Osteomyelitis according to international consensus guideline* (3 of 5 criteria apply for diagnosis)
•Presence of a severe nephropathy (creatinine clearance < 30 ml/min)
•Advanced diabetical 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
•Immunosupression (oral immunosupressiva, Corticoids exaggerating 7.5 mg Prednisolon-equivalents)
•Chronic liver disease (AST or ALT increased to 10fold, Billirubine increased to threefold compared to normal values)

发起方

Heart- and Diabetescenter NRW