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

Ruhr University of Bochum

Status and phase

Terminated

Phase 3

Conditions

Diabetic Foot

Treatments

Drug: Vancomycin

Drug: Daptomycin

Study type

Interventional

Funder types

Other

Identifiers

NCT01199783

MCBC134ADE02T

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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)