Patients eligible for this study suffer from diabetic foot infections.
Conditions
Interventions
Trade Name: Cubicin
Product Name: Cubicin
Product Code: J01XX09
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: DAPTOMYCIN
CAS Number: 103060-53-3
Current Sponsor code: MCBC
Sponsors
Heart- and Diabetescenter NRW
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •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
Exclusion criteria
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 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Clinical response of the infectionat test-of-cure (TOC) 14 days post therapy;Secondary Objective: • Duration of therapy • Number of successful treatments from the clinician point of view (clinical signs and symptoms) from microbiological analysis • Rate of amputations due to infection • Therapy related complications;Primary end point(s): Clinical response of the infection at test-of-cure (TOC) 14 days post therapy | — |
Countries
Germany
Outcome results
None listed