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

Condition(s) targeted: Diabetic Foot

Intervention: Daptomycin (Drug); Vancomycin (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Ruhr University of Bochum

Official(s) and/or principal investigator(s):
Diethelm Tschoepe, Prof Dr Dr, Principal Investigator, Affiliation: Herz- und Diabeteszentrum NRW

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Clinical response of the infection at test-of-cure (TOC) at day 14 post therapy

Secondary outcome:

Duration of therapy

Therapy related complications

Number of successful treatments at TOC

Rate of amputations due to infection

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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)

Herz- und Diabeteszentrum, Bad Oeynhausen 32545, Germany

Starting date: July 2011
Last updated: May 4, 2015